Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gaucher Disease Type 2

Peripheral blood mononuclear cells (PBMCs) of patients who have GD2, PSMA, Muc1 or Mesothelin positive cervical cancer will be obtained through apheresis, and T cells will be activated and modified to cervical cancer-specific CAR-T cells.

1 infusion, for 1x10\^6\~1x10\^7 cells/kg via IV

Cervical cancer-specific CAR-T cells

Lung-Ji Chang, PhD

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

Cervical cancer is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of cases. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, cervical cancer is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of cervical cancer consists of surgical intervention, radiation, chemotherapy and immunotherapy.

In this study, the participant's T-cells will be collected and modified. Then the modified T cells, called chimeric antigen receptor modified-T cells (CAR T) which can recognize specific molecules that are expressed on the surface of cervical cancer cells, are given back to the participant by intravenous infusion.

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

Intervention of CAR-T Against Cervical Cancer

Multicenter Trial of Chimeric Antigen Receptor-Modified T Cells (CAR-T Cells) in the Treatment of Cervical Cancer

Physiological parameter (measuring cytokine response)

The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.

Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Shenzhen Geno-Immune Medical Institute

President

Symptoms and General Pathology

Recurrence

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Immunomodulating Agents

Immunologic Factors

Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen by infusion.

This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.

CAR-T cell immunotherapy

Lizhi Niu, PhD

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor aiming at GD2 antigen. After CAR-T cell infusion, At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study, the investigators will evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma

It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Fuda Cancer Hospital, Guangzhou

Treated by GD2 CAR-T therapy intravenously

GD2 CAR-T immunotherapy

Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor aiming at GD2 antigen.After CAR-T cell infusion,At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study,the investigators will evaluate the safty and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

To observe the common 1-4 levels of side effects

PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Peripheral blood mononuclear cells (PBMCs) of patients, who have cancer antigen identified lung cancer, will be obtained through apheresis, and T cells will be activated and ex vivo engineered.

Lung cancer-specific T cells

Qichun Cai, MD

Xun Lai, MD

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of cancer antigen-specific T cells targeting lung cancer. The cancer targeting antigens are identified through immunostaining of patient's cancer specimens. Another goal of the study is to learn more about the persistence and function of the ex vivo manipulated antigen-specific T cells in the body.

Lung cancer is a malignancy characterized by uncontrolled cell growth in tissues of the lung. There are two main types of lung cancer, small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC). In 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths worldwide. Common treatments include surgery, chemotherapy, and radiotherapy, but in relapsed cancer patients, such treatments often have limited successes.

In this study, the participant's peripheral blood mononuclear cells will be collected for antigen-specific T cell preparation, and/or modified using an advanced lentiviral vector system. Then the antigen-specific T cells, called engineered immune effectors (EIEs) or chimeric antigen receptor modified-T cells (CAR T), which can recognize specific molecules that are expressed by the lung cancer cells, are given back to the participant by intravenous infusion.

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of T cell immunotherapy targeting single or multiple cancer antigens. The lung cancer antigens include known tumor antigens such as MAGE-A1, MAGE-A4, MucI, GD2, and mesothelin, as well as novel cancer antigens. Another goal of the study is to learn more about the persistence and function of the specific CAR T cells in the body.

Antigen-specific T Cells Against Lung Cancer

Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer

The expansion and functional persistence of ex vivo engineered T cells in the peripheral blood of patients will be examined on Day 7, 14, 21, 28, 60 and 90 after infusion.

Infections

Skin and Connective Tissue Diseases

Osteosarcoma

Neuroblastoma

Sarcoma

Virus Diseases

Herpes Zoster

Chickenpox

Neoplasms, Connective and Soft Tissue

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Antineoplastic Agents

Antirheumatic Agents

Antiemetics

Gastrointestinal Agents

Emetics

Vaccines

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Mesna

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

In this study we will be administering from 1 x 10\^6 to 1 x 10\^9 transduced autologous VZV-specific CTLs, derived from VZV-specific memory T cells, so there will be no risk of alloreactivity. 6.1.1 Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m2/day followed by Fludarabine 30 mg/m2/day.

On dose levels 1 and 2 each patient receives one injection of GD2 T cells followed by VZV vaccine injection 42 days later.

Dose Level 1: 1x10\^6 cells/m\^2

Dose Level 2: 1x10\^7 cells/m\^2

The next dose levels to be studied following Dose level 2 are Dose levels 7 and 8 where subjects will receive the VZV vaccine followed by a single infusion of iC9-GD2-CAR-VZV-CTLs within 48 hours after VZV vaccine:

Dose Level 7: 1 x 10\^7 cells/m2

Dose Level 8: 1 x 10\^8 cells/m\^2

Dose levels 9-11 will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to administration of the T cells.

Dose Level 9: 1 x 10\^8 cells/m\^2

Dose Level 10: 5 x 10\^8 cells/m\^2

Dose Level 11: 1 x 10\^9 cells/m\^2

The previously planned dose levels 3-6 will not be studied.

GD2 T cells

Subjects will receive a VZV vaccine with CTL infusion within 48 hours after the vaccine.

VZV vaccine

Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m\^2/day followed by Fludarabine 30 mg/m\^2/day. Infusions should be given following hospital/pharmacy recommendations however at a minimum the cyclophosphamide should be infused over 1 hour and the fludarabine should be infused over 30 minutes. Mesna, IV hydration, and anti-emetics will be provided following local institutional guidelines. T cell infusion will take place the day after completion of chemotherapy. Zostavax will be administered two weeks after infusion of T cells.

Lisa L Wang, MD

Sarah Whittle, MD

Cliona Rooney, PhD

The purpose of this study is to find the largest safe dose of GD2-T cells (also called iC9-GD2-CAR-VZV-CTLs) in combination with a varicella zoster vaccine and lymohodepleting chemotherapy. Additionally, we will learn what the side effects of this treatment are and to see whether this therapy might help patients with advanced osteosarcoma and neuroblastoma. Because there is no standard treatment for recurrent/refractory osteosarcoma and neuroblastoma at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells.

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.

Investigators have found from previous research that a new gene can be put into T cells that will make them recognize cancer cells and kill them. Investigators now want to see if a new gene can be put in these cells that will let the T cells recognize and kill sarcoma and neuroblastoma cells. The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called 14g2a that recognizes GD2, a protein that is found on sarcoma and neuroblastoma cells (GD2-CAR). In addition, it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live longer.

Investigators have found that CAR-T cells can kill some of the tumor, but they don't last very long in the body and so the tumor eventually comes back. T cells that recognize the virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for many years especially if they are stimulated or boosted by the VZV vaccine. Investigators will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.

Patients give blood to make GD2-T cells that are grown and frozen. To get the GD2-CAR to attach to the surface of the T-cell, a gene is inserted into the T-cell. As described in the Brief Summary, the gene contains the GD2-CAR. This is done using part of a virus (known as a retrovirus) that has been put into a vector made for this study and that will carry the antibody gene into the T cell. This retrovirus vector also helps identify the T cells in the patient's blood after they have been injected. Because the patients have received cells with a new gene in them they will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.

When enrolled on this study, patients will be assigned to one of three groups of different doses of GD2-T cells. The first group of patients will receive a lower dose of GD2-T cells. Once that dose schedule proves safe, the next group of patients will be started at the higher dose. Patients will receive treatment with with cyclophosphamide (cytoxan) and fludarabine for 3 days before receiving the T-cell infusion. These drugs will decrease the numbers of your own T cells before we infuse the GD2-T cells.

Patients will receive the GD2-T cells by an intravenous line. Before patients receive the injection, they may be given a dose of Benadryl and Tylenol. The injection will take between 1 and 25 minutes. The research team will follow patients in the clinic after the injection for 1 to 4 hours. Two weeks after receiving the dose of GD2-T cells, patients will receive a dose of the VZV vaccine. This will be given as an injection under the skin that will take less than a minute. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital. Patients may need to stay in Houston for up to 4 weeks after the infusion so the research team can monitor patients for side effects. The research team will follow patients in the clinic or through communication with their primary doctor after the GD2-T-cell injection.

Medical tests before treatment--

Before being treated, patients will receive a series of standard medical tests:

* Physical exam and History
* Blood tests to measure blood cells, kidney and liver function
* A urine pregnancy test. If you a patient is pregnant, both the patient and her parents will be informed of the pregnancy
* Measurements of their tumor by routine imaging studies. We will use the imaging study that was used before to follow the patient's tumor (Computer Tomogram (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography(PET/CT)

Medical tests during and after treatment--

Patients will receive standard medical tests when they are getting the infusions and afterwards:

* Physical exams
* Blood tests to measure blood cells, kidney and liver function
* Measurements of their tumor by routine imaging studies at 6 weeks after the infusion

To learn more about the way the GD2-T cells are working and how long they last in the body, an extra amount of blood, based on the patient's weight, up to a maximum of 60 ml (12 teaspoons) of blood will be taken on the day of the GD2-T- cell infusion(s), (before and at the end of the T-cell infusion(s)), 1, 2, 4, and 6 weeks after the GD2-T-cell infusion(s) and every 3 months for 1 year, at 15 months and 18 months, then every 6 months for 4 years, then yearly for a total of 15 years. One additional blood sample might be drawn 3 to 4 days after the GD2-T-cell infusion(s); this is optional. Blood may be drawn at additional time points based on the patient's response to the treatment.

During the time points listed above, if the Tcells are found in patient's blood at a certain amount, an extra 5ml of blood may need to be collected for additional testing.

For children, the total amount of blood drawn will not be more than 3 ml (less than 1 teaspoon) per 2.2 pounds of body weight on any one day. This volume is considered safe, but may be decreased if the patient is anemic (have a low red blood cell count).

iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma

Vaccination to Enhance the Anti-Tumor Activity of GD2 Chimeric Antigen Receptor-Expressing, VZV-Specific T Cells in Subjects With Advanced Sarcomas and Neuroblastoma (VEGAS)

The primary objective is to evaluate the safety and feasibility of intravenous injections of autologous iC9-GD2-CAR-VZV-CTLs in combination with VZV vaccination in patients with advanced GD2-positive sarcomas or neuroblastoma.

To assess the effects of VZV vaccination on the in vivo expansion and persistence of transgenic VZV-specific T cells

To assess the in vivo persistence of infused T cells using immunoassays and transgene detection

To assess the anti-tumor effects of the infused GD2-specific T cells

To assess the effect of of myeloid derived suppressor cells (MDSC) on expansion and persistence of infused T cells.

Evaluations of tumor size will be performed within 4 weeks of beginning treatment and 6 weeks (before the vaccine) and 12 to 14 weeks after the iC9-GD2-CAR-VZV-CTL injection. All patients who receive the first infusion will be evaluable for response.

National Cancer Institute (NCI)

Center for Cell and Gene Therapy, Baylor College of Medicine

The Methodist Hospital Research Institute

Baylor College of Medicine

Assistant Professor

Syndrome

Cytokine Release Syndrome

Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 intravenously (IV) on Day 0.

Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.

If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).

Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.

Leukapheresis

1RG-CART

John Anderson, Prof

The purpose of this first in human study is to determine the safety and feasibility of 1RG-CART therapy in patients with relapsed or refractory neuroblastoma. 1RG-CART therapy is a novel immunotherapy under investigation in which patients have their T-cells (a type of white blood cell) collected and modified in the laboratory, before they are given back to the patient. The T-cells are modified to express a chimeric antigen receptor (CAR) which targets disialoganglioside (GD2), a marker expressed on the surface of neuroblastoma cells.

The purpose of this trial is to explore the safety and feasibility of deploying autologous anti-GD2 CAR T-cells for the immunotherapy of neuroblastoma. The CAR T-cell trials employing second generation receptors and lymphodepleting conditioning regimes have produced objective clinical responses in patients with relapsed leukaemias. The trial aims to evaluate similar CAR T-cells but directed against the antigen GD2. Neuroblastoma is well suited to this form of targeted therapy because of the homogeneous and almost universal expression of GD2 on the surface of neuroblastoma cells, and because of the poor prognosis of eligible patients.

1RG-CART will be administered intravenously. As the CAR T-cells are designed to survive and proliferate on encountering antigen, no direct relationship is anticipated between cell dose and either efficacy or toxicity. Rather, clinical benefit is more likely to be observed in those patients in whom in vivo expansion successfully occurs. A possible key determinant of expansion will be prior lymphodepletion of the patients. For this reason this trial is designed to evaluate a phased introduction of lymphodepletion in successive patient cohorts, rather than T-cell dose escalation. Only if there is insufficient expansion of T-cells following full lymphodepletion will the T-cell dose be escalated. Rituximab (MabThera®) will be used as a rescue medication only when necessary, and will be considered a non-investigational medicinal product (NIMP) in this trial.

A Phase I Trial of Anti-GD2 T-cells (1RG-CART)

A Cancer Research UK Phase I Trial of Anti-GD2 Chimeric Antigen Receptor (CAR) Transduced T-cells (1RG-CART) in Patients With Relapsed or Refractory Neuroblastoma

Feasibility of 1RG-CART therapy assessed as the number of patients who commence T-cell processing and are subsequently evaluable for 1RG-CART engraftment at Day 14.

Number of serious adverse events, non-serious adverse events and adverse events that are related to fludarabine, cyclophosphamide or 1RG-CART.

Number of dose limiting toxicities (DLTs) at each dose level.

Number of patients with 1RG-CART levels in peripheral blood above the limit of quantification for the assay (10 cells/µL) by flow cytometry.

Assessment of best tumour response from baseline according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

Assessment of best tumour response from baseline according to Immune Related Response Criteria (irRC).

Assessment of best tumour response from baseline according to International Neuroblastoma Response Criteria (INRC).

Progression free survival (progression by RECIST criteria).

Cancer Research UK

Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.

Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis

1RG-CART

Dose Level 1

Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis

Cyclophosphamide

1RG-CART

Dose Level 2

Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis

Cyclophosphamide

Fludarabine

1RG-CART

Dose Level 3

Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis

Cyclophosphamide

Fludarabine

1RG-CART

Dose Level 4

If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).

Assigned Interventions:

Leukapheresis

Cyclophosphamide

Fludarabine

1RG-CART

Dose Level 5

Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Cyclophosphamide

Fludarabine

Leukapheresis

1RG-CART

Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Cyclophosphamide

Fludarabine

Leukapheresis

1RG-CART

If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).

Assigned Interventions:

Cyclophosphamide

Fludarabine

Leukapheresis

1RG-CART

Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.

Assigned Interventions:

Leukapheresis

Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United Kingdom

Region of Enrollment

For the secondary outcome measure of Overall Survival, one patient from Dose Level 1 withdrew consent to continue with the trial, therefore the time to death (if applicable) for this patient was not collected.

Regulatory Affairs Manager

Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis Cyclophosphamide

1RG-CART/m\^2

Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis Cyclophosphamide Fludarabine

1RG-CART/m\^2

Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis Cyclophosphamide Fludarabine

1RG-CART/m\^2

If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).

Assigned Interventions:

Leukapheresis Cyclophosphamide Fludarabine

1RG-CART/m\^2

All eligible patients enrolled for leukapheresis/venepuncture. Patients who were enrolled for leukapheresis/venepuncture in error (due to ineligibility or administrative error) were excluded.

To Evaluate the Feasibility of 1RG-CART Therapy in Patients With Relapsed or Refractory Neuroblastoma

SAEs

NSAEs

Fludarabine Related AEs

Cyclophosphamide Related AEs

1RG-CART Related AEs

Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis

Cyclophosphamide

Fludarabine

1RG-CART/m\^2

Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis

Cyclophosphamide

Fludarabine

1RG-CART/m\^2

If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).

Assigned Interventions:

Leukapheresis

Cyclophosphamide

Fludarabine

1RG-CART/m\^2

All eligible patients who received at least one dose of 1RG-CART, cyclophosphamide or fludarabine.

Safety and Tolerability of 1RG-CART Therapy

Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.

Assigned Interventions:

Leukapheresis

Cyclophosphamide

1RG-CART/m\^2

To Determine Recommended Phase II Regimen by Assessing the Number of DLTs at Each Dose Level

All eligible patients who received 1RG-CART and provided at least one post-treatment blood sample taken on or after Day 14 for 1RG-CART analysis.

1RG-CART Counts in the Peripheral Blood

Best Response (RECIST) stable disease (SD)

Best Response (RECIST) progressive disease (PD)

All eligible patients who received at least one dose of 1RG-CART and had a baseline assessment of disease and at least one repeat disease assessment measured according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

Assessment of Tumour Response From Baseline (RECIST)

Best Response (irRC) stable disease (irSD)

Best Response (irRC) progressive disease (irPD)

Best Response (irRC) not evaluable (NE)

All eligible patients who received at least one dose of 1RG-CART and had a baseline assessment of disease and at least one repeat disease assessment measured according to Immune Related Response Criteria (irRC).

Assessment of Tumour Response From Baseline (irRC)

f the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).

Assigned Interventions:

Leukapheresis

Cyclophosphamide

Fludarabine

1RG-CART/m\^2

All eligible patients who received at least one dose of 1RG-CART and had a baseline assessment of disease and at least one repeat disease assessment measured according to International Neuroblastoma Response Criteria (INRC).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intervention of CAR-T Against Cervical Cancer	NCT03356795	Cervical Cancer	Cervical cancer...	18 Years - 70 Years	Shenzhen Geno-Immune Medical Institute
CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients	NCT03252171	GD2 Positive Gl... CAR-T Cell Immu...	CAR-T cell immu...	18 Years - 80 Years	Fuda Cancer Hospital, Guangzhou
CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients	NCT04406610	Glioma of Brain CAR-T Cell Immu...	GD2 CAR-T immun...	30 Years - 70 Years	Fuda Cancer Hospital, Guangzhou
Antigen-specific T Cells Against Lung Cancer	NCT03356808	Lung Cancer	Lung cancer-spe...	18 Years - 80 Years	Shenzhen Geno-Immune Medical Institute
iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma	NCT01953900	Osteosarcoma Neuroblastoma	GD2 T cells VZV vaccine Fludarabine Cyclophosphamid...	-	Baylor College of Medicine
Intervention of CAR-T Against Cervical Cancer	NCT03356795	Cervical Cancer	Cervical cancer...	18 Years - 70 Years	Shenzhen Geno-Immune Medical Institute
A Phase I Trial of Anti-GD2 T-cells (1RG-CART)	NCT02761915	Relapsed or Ref...	Leukapheresis Cyclophosphamid... Fludarabine 1RG-CART	1 Year -	Cancer Research UK
Anti-GD2 4th Generation CART Cells Targeting Refractory and/or Recurrent Neuroblastoma	NCT02765243	Neuroblastoma Effects of Immu...	Anti-GD2 CART	1 Year - 14 Years	Zhujiang Hospital
Anti-GD2 4th Generation CART Cells Targeting Refractory and/or Recurrent Neuroblastoma	NCT02765243	Neuroblastoma Effects of Immu...	Anti-GD2 CART	1 Year - 14 Years	Zhujiang Hospital
CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients	NCT04406610	Glioma of Brain CAR-T Cell Immu...	GD2 CAR-T immun...	30 Years - 70 Years	Fuda Cancer Hospital, Guangzhou

Spots Global Cancer Trial Database for gd2

Every month we try and update this database with for gd2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gd2

Every month we try and update this database with for gd2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gd2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.