OncoMatch/Clinical Trials/NCT06880354
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
Is NCT06880354 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CLL1 and CD38 Dual-Target CAR-T Cell for acute myeloid leukemia.
Treatment: CLL1 and CD38 Dual-Target CAR-T Cell — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A overexpression (positive)
Positive expression of CLL1 and/or CD38 in tumor cells
Required: CD38 overexpression (positive)
Positive expression of CLL1 and/or CD38 in tumor cells
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CAR-T cell therapy
Have previously been received CAR-T therapy, CAR-NK therapy or any other genetically modified cell therapy
Cannot have received: CAR-NK cell therapy
Have previously been received CAR-T therapy, CAR-NK therapy or any other genetically modified cell therapy
Cannot have received: genetically modified cell therapy
Have previously been received CAR-T therapy, CAR-NK therapy or any other genetically modified cell therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: within 6 months before screening phase
Received allogeneic hematopoietic stem cell transplantation within 6 months before screening phase
Cannot have received: systemic anti-tumor therapy
Exception: within 14 days before apheresis or within five half-lives of the drug, whichever was shorter
Received systemic anti-tumor therapy within 14 days before apheresis or within five half-lives of the drug, whichever was shorter, including but not limited to cytotoxic therapy, targeted therapy, or an investigational drug treatment
Cannot have received: radiotherapy
Exception: within 4 weeks before apheresis
Received radiotherapy 4 weeks before apheresis
Cannot have received: donor lymphocyte infusion
Exception: within 6 weeks before apheresis
Received donor lymphocyte infusion within 6 weeks before apheresis
Cannot have received: major surgery
Exception: within 4 weeks prior to apheresis or a plan to receive surgeries during the study (except for diagnostic biopsy)
Receipt of major surgery within 4 weeks prior to apheresis or a plan to receive surgeries during the study (except for diagnostic biopsy)
Cannot have received: live attenuated vaccine
Exception: within 4 weeks prior to screening
Received live attenuated vaccine within 4 weeks prior to screening
Lab requirements
Kidney function
Serum creatinine clearance > 45mL/min (Cockcroft-Gault formula)
Liver function
Alanine aminotransferase/aspartate aminotransferase ≤2.5× ULN; Total serum bilirubin ≤2× ULN, except in subjects with congenital bilirubinemia (direct bilirubin ≤1.5× ULN in subjects with Gilbert's syndrome)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥45%; Basal finger oxygen saturation ≥92% in room air
Adequate functional reserve of organs: Alanine aminotransferase/aspartate aminotransferase ≤2.5× ULN; Total serum bilirubin ≤2× ULN, except in subjects with congenital bilirubinemia (direct bilirubin ≤1.5× ULN in subjects with Gilbert's syndrome); Serum creatinine clearance > 45mL/min (Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥45%; Basal finger oxygen saturation ≥92% in room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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