A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Trial Parameters
Brief Summary
This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects.
Eligibility Criteria
Inclusion Criteria: 1. At the time of signing the informed consent, 18-70 years old (including the critical value); 2. Diagnosed with acute myeloid leukemia (except for APL) based on the World Health Organization (WHO) 2022 criteria and meeting the diagnostic criteria for relapsed/refractory AML (refer to the 2023 Chinese Guidelines for the Diagnosis and Treatment of relapsed refractory acute myeloid leukemia); 3. Positive expression of CLL1 and/or CD38 in tumor cells; 4. Estimated survival ≥3 months; 5. Have a confirmed donor for allogeneic hematopoietic stem cell transplantation. After the CAR-T cells were infused, subjects could undergo potential allogeneic hematopoietic stem cell transplantation at any time; 6. ECOG score of 0\~2 during the screening phase; 7. Adequate functional reserve of organs: 1. Alanine aminotransferase/aspartate aminotransferase ≤2.5× ULN; 2. Total serum bilirubin ≤2× ULN, except in subjects with congenital bilirubinemia (direct bilirubin ≤1.5× ULN in subjec