Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B-cell Non-hodgkin Lymphoma
Conditions
Brief summary
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
Detailed description
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.
Interventions
BIOLOGICALAnti-CD19 Universal CAR-T Cells injection
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.
Sponsors
Gracell Biotechnologies (Shanghai) Co., Ltd.
Kunming Hope of Health Hospital
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group Performance Status of 0 or 1； 2. Expected survival time ≥12 weeks; 3. Adequate hematological, renal and liver function; 4. Subjects understand and voluntarily sign the informed consent form. Key
Exclusion criteria
1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ; 2. Cyclophosphamide or fludarabine is contraindicated for subjects ; 3. Active central nervous system (CNS) involvement by malignancy； 4. Active infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities | Up to 4 weeks after CAR-T infusion | Incidence of dose-limiting toxicities as protocol-defined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | At 4,12,24 weeks after CAR-T infusion | Objective response rate after CAR-T infusion |
Countries
China
Contacts
Primary ContactSanbin Wang, Professor
Outcome results
None listed