To Evaluate the Safety and Tolerability of Human CD19-CD22 Targeted T Cells Injection for Subjects With R/R B-ALL.
NCT05223686 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2022-02-04
Summary
To evaluate the safety and tolerability of Human CD19-CD22 Targeted T Cells Injection for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19-CD22 CAR+ T cells.
Conditions
Interventions
- DRUG
-
Human CD19-CD22 Targeted T Cells Injection
One time single predetermined dose level CAR-positive T cells will be utilized based on the NMPA approved product label.
Sponsors & Collaborators
-
Ruijin Hospital
collaborator OTHER -
Hrain Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianqing Mi, Doctor · Ruijin Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-10
- Primary Completion
- 2023-06-10
- Completion
- 2025-03-10
Countries
- China
Study Locations
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