CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)
Phase 2
- Conditions
- Relapsed/Refractory AML
- Interventions
- Biological: CD123/CLL1 CAR-T Cells
- Registration Number
- NCT03631576
- Lead Sponsor
- Fujian Medical University
- Brief Summary
The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Signed written informed consent
- Aged < 70 years
- Patients with relapsed/refractory AML
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
- Performance status: Karnofsky ≥ 70%
Exclusion Criteria
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 CD123/CLL1 CAR-T Cells CD123/CLL1 CAR-T Cells treat
- Primary Outcome Measures
Name Time Method Leukemia free survival 1 year
- Secondary Outcome Measures
Name Time Method Adverse events that are related to treatment 1 year
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China