Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.

CD19-STAR-T cells

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies (such as NHL and ALL ).

This Phase I study is designed as a pilot trial evaluating the safety and of CD19-STAR-T cell therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19-STAR-T cells. Safety and efficacy of CD19-STAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19-STAR-T cells therapy in patients with refractory and relapsed B-cell malignancies.

CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients

CD19-STAR-T for Patients With B Cell Malignancies

Percentage of participants with adverse events.

The percentage of participants who achieved complete remission (CR) and partial remission over all participants.

China Immunotech (Beijing) Biotechnology Co., Ltd.

Hebei Yanda Ludaopei Hospital

Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, B-Cell

Leukemia, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphoma, Non-Hodgkin

Chronic Disease

Disease Attributes

B-cell Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Chronic Graft Versus Host Disease

Immunomodulating Agents

CAR-ITNK cells will be infused over 10-15 minutes on Day 0.

CAR-ITNK cells

Ren Lin, MD

Qifa Liu

Qi-fa Liu

Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimeric antigen receptor (CAR-ITNK cells) is a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of CAR-ITNK cells infusions in patients with relapsed and refractory B cell malignancies.

Induced-T Cell Like NK Cells for B Cell Malignancies

Induced-T Cell Like NK Cellular Immunotherapy for Refractory B Cell Malignancies

Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.

Nanfang Hospital, Southern Medical University

Professor

Infections

Burkitt Lymphoma

Autologous 4th generation anti-CD19-CAR T cells

Autologous 4th generation withdrawable lentiviral-transduced anti-CD19-CAR T cells

Anti-CD19 CAR T cells

Jun Zhu, MD

Currently, a majority of B cell lymphomas cannot be cured by standard chemo-radiotherapy. Most B cell lymphomas express cluster of differentiation antigen 19 (CD19), which represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will evaluate a novel 4th generation CD19 CAR engineered with a self-withdrawal mechanism (19273-4SCAR) for both efficacy and safety in lymphoma patients.

CD19 single chain antibody-based chimeric antigen receptor (CAR)-engineered T cells have demonstrated great clinical potential in treating chronic and acute B cell leukemias. B cell lymphomas, similar to B cell leukemias, express CD19 surface molecules, and the majority of the B cell lymphoma patients cannot be cured by standard chemo-radiotherapy. CD19 CAR-based adoptive T cell therapy is associated with an unwanted adverse effect, the loss of CD19 B cells, which results in humoral immune deficiency. This study will evaluate a novel 4th generation CD19 CAR engineered with a self-withdrawal genetic mechanism (19273-4SCAR) for both efficacy and safety in lymphoma patients. The 4th generation design of the CAR incorporates the intracellular signaling domain of cluster of differentiation antigen 27 (CD27), known to be associated with T cell activation, survival and longevity. The inducible caspase 9 self-withdrawal design allows for rapid elimination of the infused CAR T cells upon complete eradication of the tumor cells, which will be followed by the recovery of humoral immunity. Patients receiving the 19273-4SCAR T cells will be closely monitored for infusion response, tumor eradication effect, longevity of the CAR T cells, and the recovery of B cell functions after withdrawal of the CAR T cells.

Evaluation of 4th Generation Safety-designed CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas

Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas

Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Measure the survival of 4th generation CAR T cells transduced with the anti-CD19 lentiviral vector.

Describe the response rates of patients treated with 4th generation CAR T cells, including partial remission (PR), complete remission (CR), stable disease (SD) and progressive disease (PD).

Evaluate the survival time of the patients treated with the 4th generation CAR T cells, including progression free survival (PFS) and overall survival (OS).

University of Florida

Peking University

Director

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma, Mantle-Cell

Lymphoma, Large B-Cell, Diffuse

Leukemia, Plasma Cell

Blood Protein Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Hemorrhagic Disorders

Mantle Cell Lymphoma

Diffuse Large B-Cell Lymphoma

Plasma Cell Leukemia

SNS01-T

John A Lust, MD, PhD

The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.

The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.

Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)

Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies

Safety and Tolerability assessed by frequency, severity, and duration of treatment-related adverse events, changes in vitals signs, physical exams and lab values

Cmax, area under curve, Tmax. Performed on Weeks 1, 3, 6, 10, 14, 18

IMWG criteria, changes in M-protein, etc. for myeloma and plasma cell leukemia; Lymphoma response criteria, CT/PET scans for B cell lymphoma

Senesco Technologies, Inc.

In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.

0.2-60 x 10\^6 CAR T cells per kg body weight.

ThisCART19 cells

Jun Li, Ph.D

Ling He

Xingbing Wang

Jun Li

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.

This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10\^6 cells per kg body weight.

Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.

To assess adverse events as dose limiting toxicities as defined by the protocol.

Proportion of patients in whom with morphologic complete remission (CR)

The mortality related with ThisCART19 infusion.

For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve CR or chronic lymphocytic leukemia(CRi); for chronic lymphocytic leukemia (CLL) and lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).

Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.

Adverse events assessed according to NCI-CTCAE v5.0 criteria

The rate of patients whom alive at year 2

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients	NCT03953599	B Cell Malignan...	CD19-STAR-T cel...	1 Year - 70 Years	Hebei Yanda Ludaopei Hospital
Induced-T Cell Like NK Cells for B Cell Malignancies	NCT04747093	B Cell Leukemia B Cell Lymphoma B-cell Acute Ly... B-cell Lymphoma... B-cell Lymphoma...	CAR-ITNK cells	18 Years - 65 Years	Nanfang Hospital, Southern Medical University
Evaluation of 4th Generation Safety-designed CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas	NCT02247609	B-cell Lymphoma...	Anti-CD19 CAR T...	18 Years -	Peking University
Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)	NCT01435720	Multiple Myelom... Multiple Myelom... Mantle Cell Lym... Diffuse Large B... Other B Cell Ly... Plasma Cell Leu...	SNS01-T SNS01-T SNS01-T SNS01-T	18 Years -	Senesco Technologies, Inc.
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies	NCT04384393	B Cell Malignan...	ThisCART19 cell...	3 Years - 70 Years	Fundamenta Therapeutics, Ltd.
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies	NCT04384393	B Cell Malignan...	ThisCART19 cell...	3 Years - 70 Years	Fundamenta Therapeutics, Ltd.

Spots Global Cancer Trial Database for b cell malignancy