RecruitingPhase 1/2

Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)

China20 participantsStarted 2023-11-04

Plain-language summary

To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
✓. At the age of 18-70 years old;
✓. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
✓. The patient has recovered from the toxicity of previous treatment;
✓. ECOG score ≤ 2 and expected survival period is not less than 3 months;
✓. 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%;
✓. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
✓. 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.

✕. Diagnosis of acute promyelocytic leukemia;
✕. History or presence of a CNS disorder;
✕. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies /mL;
✕. History of severe hypersensitivity reaction;

Dose-limiting toxicity #DLT#

Timeframe: Baseline up to 28 days after CAR-T cells infusion

NCT IDNCT06125652

SponsorXuzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Kailin Xu, MD.,PD.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
✓. At the age of 18-70 years old;
✓. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
✓. The patient has recovered from the toxicity of previous treatment;
✓. ECOG score ≤ 2 and expected survival period is not less than 3 months;
✓. 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%;
✓. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
✓. 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.

✕. Diagnosis of acute promyelocytic leukemia;
✕. History or presence of a CNS disorder;
✕. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies /mL;
✕. History of severe hypersensitivity reaction;