OncoMatch/Clinical Trials/NCT05995041
Universal CAR-T Cells Targeting AML
Is NCT05995041 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells for acute myeloid leukemia.
Treatment: CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells — The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A overexpression
Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry
Required: IL3RA overexpression
Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry
Required: CD38 overexpression
Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry
Required: CD33 overexpression
Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry
Demographics
Prior therapy
Cannot have received: gene therapy
Lab requirements
Blood counts
Hgb≥80g/L
Kidney function
creatinine ≤ 2.5 × upper limit of normal
Liver function
AST and ALT ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL
Cardiac function
cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. Hgb≥80g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05995041 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy disqualifies patients from enrollment.
Does this trial require CLEC12A?
Yes, CLEC12A overexpression is a required biomarker for enrollment.
Does this trial require IL3RA?
Yes, IL3RA overexpression is a required biomarker for enrollment.
Does this trial require CD38?
Yes, CD38 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages