B Cell Lymphoma
Conditions
Keywords
CD19, CAR T Cells, Lymphoma
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.
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.
Interventions
BIOLOGICALCD19-targeting CAR T Cells infusion
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Relapsed or refractory CD19+ B-cell lymphoma. 2. Measurable disease. 3. Performance status ECOG 0-2. 4. Age:18-80. 5. Fertile females/males must consent to use contraceptives during participation of the trial. 6. Signed informed consent
Exclusion criteria
1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. 2. Patients with primary CNS lymphoma. 3. Known human immunodeficiency virus (HIV) infection. 4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). 5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. 6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. 7. Patients that do not consent to that tissue and blood samples are stored in a biobank. 8. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tumor load | up to 24 months | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| B cell number and immunoglobulins | up to 24 months | Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics |
Countries
China
Outcome results
None listed