UnknownPhase 1/2

Administration of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)

China20 participantsStarted 2022-04-01

Plain-language summary

To evaluate the safety and efficacy of anti-Siglec-6 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;
✕. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
✕. History of organ transplant surgery;
✕. Required systemic application of immunosuppressive or other drugs;
✕. Auto-SCT within the 3 months before enrollment;

Dose-limiting toxicity（DLT）

Timeframe: Baseline up to 28 days after T cell infusion

NCT IDNCT05488132

SponsorXuzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

Kailin Xu, M.D., Ph.D.

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;
✕. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
✕. History of organ transplant surgery;
✕. Required systemic application of immunosuppressive or other drugs;
✕. Auto-SCT within the 3 months before enrollment;