Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Pancreatic Neoplasms

Liver Neoplasms

Mesothelioma

Mesothelioma, Malignant

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Malignant Mesothelioma

All Drugs and Chemicals

Immunomodulating Agents

Transfer γδT cells into patients for anti-ancer therapy.

Cell therapy for solid tumors

Zhenfeng Zhang, MD, PhD

Bingjia He, MD

The third generation of GPC3/mesothelin targeted CAR-γδT cells have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-γδT cells for immunotherapy of human cancer patients with GPC3 or Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin-CAR-γδT cell immunotherapy on human cancers will firstly be evaluated.

1. Choose appropriate patients with advanced solid cancers, with written consent for this study;
2. Perform biopsy to determine the expression of GPC3 or Mesothelin of the tumors by western blotting or IHC;
3. Collect blood from the patients and isolate mononuclear cells, select and grow γδT cells and transfect the γδT cells with GPC3 or Mesothelin targeting CAR, amplify the transfected γδT cells as needed, test the quality and killing activity of the CAR-γδT cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.

GPC3/Mesothelin-CAR-γδT Cells Against Cancers

GPC3/Mesothelin Targeted CAR-γδT for Immunotherapy of Solid Cancer: Phase I Clinical Trial

A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the γδT cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.

Median γδT cell persistence will be measured by quantitative rt-PCR.

Second Affiliated Hospital of Guangzhou Medical University

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Diseases

* Dose to be administered: a single dose
* IV administration
* Dosing rate: To be administrated at a rate of approximately 2 mL/min

EU307 CAR-T Cell

subin kim

Bo-Hyun Kim, MD, PhD

Do-Young Kim, MD, PhD

Jae-Young Jang, MD, PhD

Pil-Soo Sung, MD, PhD

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy

A Dose-escalation, Single-arm, Open-Label, Phase 1 Study

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307

A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 Targeted Chimeric Antigen Receptor T Cell Therapy in Patients With GPC3 Positive Advanced Hepatocellular Carcinoma Who Have Failed Standard Therapy

-To explore relationship to tumor response, parameters to be analyzed include, but are not limited to: IFN-g, TNF-a, IL-2, IL-6, IL-18, IL-10, RANTES, MCP-1, TGF--Analysis of T cells and immune cells

In this study, DLT is defined as an AE related to the IP (EU307),and severity will be assessed according to NCI-CTCAE v5.0

Proportion of subjects with confirmed CR or partial response (PR) as best overall response (BOR)

Time from confirmed tumor response (CR or PR) to confirmed progressive disease (PD)

Proportion of subjects with confirmed CR, PR, or stable disease (SD) (≥ 6 weeks) as BOR

Time from IP dosing to confirmed objective response (CR or PR)

Time from IP dosing to PD or all-cause death, whichever is earlier

Eutilex

Vaccines

Patients will be assigned to three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

DNA plasmid delivered via IM injection + electroporation using TERESA device

1mg NWRD06 administered by electroporation

4mg NWRD06 administered by electroporation

8mg NWRD06 administered by electroporation

Defang Liu, Ph.D.

Zhen Huang, M.D.

Hong Zhao, M.D.

Zhao Hong, Ph.D.

This is a dose escalation Phase 1 clinical study to evaluate the safety and immunogenicity of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after radical resection.

This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum tolerated dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.

Immunologic reactogenicity in blood samples was assessed at week 0, week 2, week 4, week 6, week 8, week 10, week 12.

Peripheral blood samples were then collected every 3 months for immunogenicity assessment until disease progression or specific immune response became undetectable or the study was withdrawn for various reasons or ended (whichever occurred first).

This study is divided into three dose groups climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle.

Three dose groups were preset in this study: dose group 1 and low-dose group \[a single dose of 1mg was administered three times at week 0, 4 and 8, respectively, with cumulative administration of 3mg\]; Dose group 2, middle-dose group \[single dose of 4mg, administered 3 times at week 0, 4, 8, respectively, cumulative administration of 12mg\]; Dose group 3, high-dose group \[a single dose of 8mg, administered at week 0, 4 and 8, a total of 3 times, cumulative administration of 24mg\].

After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration.

NWRD06 DNA Plasmid for HCC After Radical Resection

Phase I Safety and Immunogenicity Study of NWRD06 in Hepatocellular Carcinoma Patients After Radical Resection

all IPD that underlie results in a publication

It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the last dosing will be classified as DLT during dosing climb.

All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events)

GPC3 specific immune response in peripheral blood

Newish Technology (Beijing) Co., Ltd.

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Testicular Neoplasms

Endometrial Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Genital Neoplasms, Male

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

Vasodilator Agents

Lipid Regulating Agents

Anticonvulsants

Vitamins

Antibodies

Niacinamide

Niacin

Nicotinic Acids

Cannabidiol

Immunoglobulins

Nicotinamide

Nicotinic Acid

Vitamin B3

Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the CAR-NK cell therapy group.

Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the IL7/CCL19 secreting CAR-NK cell therapy group.

Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the PD1/PDL1/CTLA4-scfv secreting CAR-NK cell therapy group.

Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the CAR-NK cell plus CBD therapy group.

Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the CAR-NK cell plus NAD therapy group.

Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.

In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.

Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells

Zhenfeng Zhang, MD, PHD

This study is an open, exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells in patients with Claudin6, GPC3, Mesothelin, or AXL-positive advanced solid tumors (ovarian cancer and others)

1. Choose appropriate advanced cancer patients with Claudin6, GPC3, Mesothelin, or AXL expression, with written consent for the study;
2. Perform PBMCs apheresis from the patient and isolate NK cells, transfect the NK cells with Claudin6, GPC3, Mesothelin, or AXL targeting CAR, amplify the number of transfected NK cells as needed, test the quality and killing activity of the Claudin6, GPC3, Mesothelin, or AXL-CAR-NK cells and then transplant back the patients via systemic or local infusions (via artery or intra-tumor), and follow up closely to collect related results as needed;
3. To enhance the killing capability, some CAR-NK cells are genetically engineered to express and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Lag3; some CAR-NK cells are combined with Cannabidiol(CBD) or Nicotinamide adenine dinucleotide (NAD);
4. Evaluate the clinical results as needed.
5. Will also perform the similar clinical trial on different cancer types with Claudin6, GPC3, Mesothelin, or AXL expression.

CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors

Phase I Trial to Evaluate Safety and Preliminary Efficacy of CLDN6/GPC3/Mesothelin/AXL-CAR-NK in Patients With CLDN6/GPC3/Mesothelin/AXL-positive Advanced Solid Tumors

The type, frequency, severity, and duration of adverse events as a result of Claudin6, GPC3, Mesothelin, or AXL- CAR-NK cells infusion will be summarized.

Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) assessed by MRI or CT. ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) is observed as best overall response, prior to progression or further anti-cancer therapy.

Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response.

Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (Progressive disease (PD) per RECIST 1.1/recurrence) or death from any cause, whichever occurs first.

Antineoplastic Agents

Antirheumatic Agents

Amino Acids

Antibodies, Monoclonal

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Tyrosine Kinase Inhibitors

Tyrosine

The subjects enrolled will be sequentially assigned to Part 1 at 3 dose levels via typical 3+3 dose escalation method and then Part 2, cohort expansion stage, 3 cohorts of CAR T therapy combination with currently available treatment for HCC. stage Part 1: Dose escalating: 3 dose level Part 2: 3 cohorts Cohort 1. Combination with tyrosine kinase inhibitors Cohort 2. Combination with PD-1 / PD-L1 monoclonal antibody Cohort 3. Combination with the drugs may benefit for patient at investigator's discretion

Pretreatment with fludarabine and cyclophosphamide CAR-GPC3 T Cells infusion

CAR-GPC3 T Cells

Tingbo Liang

A Phase I Clinical Study of 4th generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 ( CAR-GPC3 T Cells) in Patients with Advanced Hepatocellular Carcinoma

This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of CAR-GPC3 T cells, infused intravenously in subjects who have been diagnosed with GPC3 positive advanced hepatocellular carcinoma and refractory or intolerant to current standard systemic treatment.

Primary objectives:

•To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at escalating doses in patients with advanced hepatocellular carcinoma.

Secondary objectives:

* To evaluate the cellular pharmacokinetics of CAR-GPC3 T cells
* To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells
* To investigate the preliminary efficacy of CAR-GPC3 T cells in the treatment of advanced hepatocellular carcinoma

4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3

A Phase I Clinical Study of 4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3 ( CAR-GPC3 T Cells) in Patients With Advanced Hepatocellular Carcinoma

1.the number of cell copies and cell persistence duration in peripheral blood) Pharmacokinetics is the "Implantation endpoint" which is defined as the number of copies of the CAR-GPC3 DNA in peripheral blood detected at each visit after infusion until any two consecutive test results are negative or below the detection limit. Duration of CAR-GPC3 T Cell persistence is the period from the day of infusion to the first negative test result or result lower than the detection limit

Adverse events occurring through18 weeks and 52weeks post infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.

Adverse events occurring through18 weeks and 52weeks post infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.

The period from the day when the subject receives the first study treatment to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause.

The period from the first evaluation of CR, PR, or SD to the first evaluation of PD or any cause of death

The period from the first study treatment to any cause of death

The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation

The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%).

CARsgen Therapeutics Co., Ltd.

Zhejiang University

Professor

Decitabine

Antibodies, Bispecific

Muromonab-CD3

Immunologic Factors

Antimetabolites

Enzyme Inhibitors

This study is a pre-phase I immunotherapy trial in 10 people with malignant solid tumor consisting of 9 infusions of bispecific antibody armed anti-CD3-Actibated T cells(ATC) to determine safety, maximum tolerated dose (MTD), technical feasibility, immune responses.

In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.

Targeted T-cell armed with bispecific antibody (Decitabine)

Zhengzheng Li, Doctor

Jiana Fan, bachelar

Zhengcheng Li, Doctor

Zeqiang Zhou, Doctor

Wenli Liang, Doctor

Liang Xiao, Doctor

Lin Lin, Doctor

Meixiang Li, Doctor

This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.

In China, malignant tumors have become the leading cause of death for urban and rural residents, with solid tumors accounting for 77 percent.Immunotherapy is considered one of the most promising ways to fight cancer.This study is a single-center, open, single-arm controlled clinical trial (after intravenous infusion of targeted T cells, compare the changes of self-lesion). The essence of this study is to collect immune cells to the surrounding of tumor cells, so that immune cells can kill tumor cells at close range.The researchers plan to enroll 10 patients with solid tumors and follow them up to the end of the study after completing 9 courses of treatment.The results of this study were statistically analyzed using RECIST1.1 records.

This is a single-center, open, single-arm controlled prospective clinical study to investigate the efficacy and safety of targeted T-cell therapy in solid tumors.

Targeted T-cell Therapy in Solid Tumors

Clinical Study of Targeted T-cell Therapy in Solid Tumors

Time tumor progression.The time of patient from randomization to objective progress of the tumor.

Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.

Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.

Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases.

Overrall survival.The time of patient from randomization to death caused by any cause.

Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.

Shenzhen Second People's Hospital

Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.

Hematinics

Liver Extracts

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

GPC3-Car (GAP T cells) along with lymphodepleting chemotherapy (Cytoxan and Fludarabine) will be administered to patients with GPC3-positive solid tumors.

Five different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule. The following dose levels will be evaluated:

DL1: 1x10\^7/m2

DL2: 3x10\^7/m2

DL3: 1x10\^8/m2

DL4: 3x10\^8/m2

DL5: 1x10\^9/m2

The doses are calculated according to the actual number of GPC3-CAR transduced T cells.

GAP T cells

Cyclophosphamide will be given at a dose of 500 mg/m2/day for 3 days given intravenously.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GPC3/Mesothelin-CAR-γδT Cells Against Cancers	NCT06196294	Pancreas Cancer Lung Cancer Liver Cancer Mesothelioma CAR-T Cell Ther... Solid Tumor, Ad...	Cell therapy fo...	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University
To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307	NCT05783570	Advanced Hepato...	EU307 CAR-T Cel...	19 Years -	Eutilex
NWRD06 DNA Plasmid for HCC After Radical Resection	NCT06088459	Hepatocellular ...	1mg NWRD06 admi... 4mg NWRD06 admi... 8mg NWRD06 admi...	18 Years - 60 Years	Newish Technology (Beijing) Co., Ltd.
CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors	NCT05410717	Stage IV Ovaria... Testis Cancer, ... Endometrial Can... CAR NK	Claudin6, GPC3,...	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University
4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3	NCT03980288	Advanced Hepato...	CAR-GPC3 T Cell...	18 Years - 75 Years	Zhejiang University
Targeted T-cell Therapy in Solid Tumors	NCT04076137	Malignant Solid...	Targeted T-cell...	18 Years - 75 Years	Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Patients With Pediatric Solid Tumors (GAP)	NCT02932956	Liver Cancer	GAP T cells Cytoxan Fludara	1 Year - 21 Years	Baylor College of Medicine
Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells for Solid Tumors	NCT05103631	Liver Cell Carc... Solid Tumor Wilms Tumor Malignant Rhabd... Yolk Sac Tumor Rhabdomyosarcom... Liposarcoma Embryonal Sarco...	CATCH T cells	18 Years -	Baylor College of Medicine
GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers	NCT03198052	Lung Cancer Cancer Immunotherapy CAR-T Cell	CAR-T cells tar...	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University
Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma	NCT04756648	Advanced Hepato...	CT0180 Cells	18 Years - 75 Years	Zhejiang University
To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307	NCT05783570	Advanced Hepato...	EU307 CAR-T Cel...	19 Years -	Eutilex

Spots Global Cancer Trial Database for gpc3

Every month we try and update this database with for gpc3 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 gpc3

Every month we try and update this database with for gpc3 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 gpc3 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.