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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06880354 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, CAR-NK cell therapy, genetically modified cell therapy disqualifies patients from enrollment.
Does this trial require CLEC12A?
Yes, CLEC12A 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 70 years or younger.
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