Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for B Lymphoid Malignancies
NCT04796675 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2021-04-08
Summary
This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD19 chimeric antigen receptor(CAR)-modified NK cells(CAR-NK-CD19) in patients with relapsed or refractory hematological malignancies.
Conditions
- Acute Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia
- Non Hodgkin's 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
-
Shanghai Simnova Biotechnology Co.,Ltd.
collaborator INDUSTRY -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Yu Hu · 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
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-10
- Primary Completion
- 2023-03-10
- Completion
- 2024-03-10
Countries
- China
Study Locations
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