CD19-targeting CAR T Cells for B Cell Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.

Detailed Description
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Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Official Title
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CD19-targeting CAR T Cells for Refractory B Cell Lymphoma

Conditions
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B Cell Lymphoma

Intervention / Treatment
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* Biological: CD19-targeting CAR T Cells infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsed or refractory CD19+ B-cell lymphoma. Measurable disease. Performance status ECOG 0-2. Age:18-80. Fertile females/males must consent to use contraceptives during participation of the trial. Signed informed consent Exclusion Criteria: Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. Patients with primary CNS lymphoma. Known human immunodeficiency virus (HIV) infection. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. Patients that do not consent to that tissue and blood samples are stored in a biobank. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAR T cells<br>In interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins. | Biological: CD19-targeting CAR T Cells infusion<br>* CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma<br>|
| No Intervention: No Intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAR T cell persistence | Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor load | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD19, CAR T Cells, Lymphoma