Safety and Efficacy of Anti-CD123 CAR-T Therapy in Patients With Refractory/ Relapsed CD123+ Acute Myeloid Leukemia.
NCT04014881 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-08-07
Summary
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD123 CAR-T cells in patients with refractory/relapsed CD123+ Acute Myeloid Leukemia.
Conditions
- CD123+ Acute Myeloid Leukemia
Interventions
- BIOLOGICAL
-
Third-generation anti-CD123 CAR-T cells
From the minimum dose, If no DLT emerges in the group, then the next group uses the subsequent higher dose. If DLT emerges in a single subject in any dose level, 3 more subjects will be enrolled to the same dose level.
Sponsors & Collaborators
-
Wuhan Bio-Raid Biotechnology 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
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-06
- Primary Completion
- 2021-07-01
- Completion
- 2022-07-01
Countries
- China
Study Locations
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