Evaluation of the Safety and Efficacy of Human CI-135 (FLT3) Targeted CAR-T Cells Injection for Subjects with Relapsed/Refractory Acute Myeloid Leukemia
NCT06760260 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-01-07
Summary
This study is a single-arm, open-label, dose-escalating trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of anti human CI-135 (FLT3) CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory Acute Myeloid Leukemia.
Conditions
- Acute Myeloid Leukemia (AML)
Interventions
- DRUG
-
Human Derived anti-CI135 CAR-T Injection
Autologous genetically modified anti-CI135 CAR transduced T cells
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
collaborator OTHER -
Hrain Biotechnology Co., Ltd.
lead INDUSTRY
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
- 2022-01-26
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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