CD19-targeting CAR T Cells for B Cell Lymphoma
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CAR T cells 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
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma
|
| No Intervention: No Intervention
|
Outcome Measures
Primary Outcome Measures
- CAR T cell persistence [up to 24 months]
Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood
Secondary Outcome Measures
- Tumor load [up to 24 months]
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Other Outcome Measures
- B cell number and immunoglobulins [up to 24 months]
Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics
Eligibility Criteria
Criteria
Inclusion Criteria:
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Relapsed or refractory CD19+ B-cell lymphoma.
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Measurable disease.
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Performance status ECOG 0-2.
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Age:18-80.
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Fertile females/males must consent to use contraceptives during participation of the trial.
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Signed informed consent
Exclusion Criteria:
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Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
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Patients with primary CNS lymphoma.
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Known human immunodeficiency virus (HIV) infection.
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Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
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Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
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Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
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Patients that do not consent to that tissue and blood samples are stored in a biobank.
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Pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central laboratory in Fuda cancer hospital | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Fuda Cancer Hospital, Guangzhou
Investigators
- Study Chair: Lizhi Niu, PhD, Fuda Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CD19-targeting CAR T