CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients.
NCT04697290 · Status: SUSPENDED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2022-02-14
Summary
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory or relapsed B-NHL.
Conditions
- B-cell Non-Hodgkin's Lymphoma
Interventions
- BIOLOGICAL
-
CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 2E6、6E6、1E7、3E7 cells/kg.
Sponsors & Collaborators
-
China Immunotech Pharmaceuticals Co.Ltd.
collaborator UNKNOWN -
Beijing Tsinghua Chang Gung Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-10
- Primary Completion
- 2023-03-10
- Completion
- 2023-06-10
Countries
- China
Study Locations
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