Universal Chimeric Antigen Receptor-modified AT19 Cells for CD19+ Relapsed/Refractory Hematological Malignancies
NCT04796688 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2021-03-15
Summary
This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of universal chimeric antigen receptor-modified AT19 cells in patients with relapsed or refractory hematological malignancies.
Conditions
- Acute Lymphoblastic Leukemia
- Chronic Lymphoblastic Leukemia
- B-cell Lymphoma
Interventions
- DRUG
-
Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells
fludarabine 30 mg/kg on day -5, -4, and -3; cyclophosphamide 300 mg/kg on day -5, -4, and -3; CAR-NK-CD19 Cells on day 0.
Sponsors & Collaborators
-
Chengdu USino Technology Biology Co., Ltd
collaborator UNKNOWN -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Heng Mei, M.D., Ph.D · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Max Age
- 78 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-10
- Primary Completion
- 2023-03-10
- Completion
- 2024-03-10
Countries
- China
Study Locations
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