OncoMatch/Clinical Trials/NCT07668557
Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Is NCT07668557 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide for acute myeloid leukemia (aml).
Treatment: Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide — This single-arm, open-label phase I trial evaluates the safety and tolerability of ICG415, autologous CAR-T cells targeting CD33 and CLL1, in patients with relapsed or refractory acute myeloid leukemia (AML). Subjects receive lymphodepleting chemotherapy followed by autologous CAR-T infusion. The primary goal is to assess safety and preliminary anti-leukemic efficacy in patients failing standard AML therapies.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A expression (positive)
Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry
Required: CD33 expression (positive)
Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry
Required: CD4 expression (negative)
tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry
Required: CD8 expression (negative)
tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: CAR-T cell therapy
Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent
Cannot have received: genetically modified cell therapy
Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent
Lab requirements
Kidney function
egfr < 50 ml/min (cockcroft-gault)
Liver function
alt/ast > 3 × uln (>5×uln if disease-related), total bilirubin > 2 × uln (>3×uln for gilbert syndrome)
Cardiac function
lvef < 50%, room air spo₂ <94%, uncontrolled severe cardiac disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07668557 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, genetically modified cell therapy disqualifies patients from enrollment.
Does this trial require CLEC12A?
Yes, CLEC12A expression is a required biomarker for enrollment.
Does this trial require CD33?
Yes, CD33 expression is a required biomarker for enrollment.
Does this trial require CD4?
Yes, CD4 expression 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