Anti-CD19/CD22 Bispecific Chimeric Antigen Receptor(CAR)-T Cell Therapy for Measurable Residual Disease(MRD) Positive ALL
NCT03919526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2023-12-08
Summary
To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive 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
- MRD-positive
- Acute Lymphoblastic Leukemia
Interventions
- BIOLOGICAL
-
anti-CD19/CD22 CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
- DRUG
-
30mg/m2/d
- DRUG
-
300mg/m2/d
Sponsors & Collaborators
-
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Xianmin Song, M.D. · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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
- 2019-08-11
- Primary Completion
- 2023-11-01
- Completion
- 2023-11-01
Countries
- China
Study Locations
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