CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
NCT05270772 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2022-03-08
Summary
This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
Conditions
- CD19+ Relapse/Refractory B-ALL
Interventions
- BIOLOGICAL
-
CAR-T-19 Cells
T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10\^6/kg,1.5×10\^6/kg, 5.0×10\^6/kg CAR+ cells.
Sponsors & Collaborators
-
Chinese PLA General Hospital
lead OTHER
Principal Investigators
-
Daihong Liu · Chinese PLA General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-25
- Primary Completion
- 2022-07-15
- Completion
- 2024-09-16
Countries
- China
Study Locations
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