A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD117 CAR-T Cell in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 15-50 participants in this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Each subject receive CD117 CAR T-cells by intravenous infusion
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Up to 28 days after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 2 years after Treatment
Complete response (CR), and complete response with incomplete hematologic recovery (CRi)
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Time frame: Up to 12 weeks after CAR-T infusion
Duration of remission ,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Time frame: Up to 1 years after CAR-T infusion
Overall survival, OS
The time from CAR-T infusion to death due to any cause
Time frame: Up to 1 years after CAR-T infusion
Leukemia-Free Survival, LFS
The time from CAR-T infusion torecurrence or metastasis
Time frame: Up to 2 years after Treatment
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