Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
Trial Parameters
Brief Summary
To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria: 1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities; 2. At the age of 18-70 years old; 3. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML); 4. The patient has recovered from the toxicity of previous treatment; 5. ECOG score ≤ 2 and expected survival period is not less than 3 months; 6. Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%; 7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test; 8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception. Exclusion Criteria: 1. Diagnosis of acute promyelocytic leukemia; 2. History or presence of a CNS disorder; 3. HBsAg is positive; HC