CAR-T cells targeting CD33 and CLL1 for relapsed or refractory AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I, open-label study evaluates the safety and tolerability of autologous anti-CD33-CLL1 CAR-T cells (ICG415) in adults with relapsed or refractory AML. After leukapheresis and CAR-T cell production, participants receive lymphodepleting chemotherapy followed by a single CAR-T infusion. The trial tracks safety outcomes such as dose-limiting toxicities and cytokine release syndrome, as well as preliminary anti-leukemic activity including response rates and MRD status, with follow-up for up to 24 months. Secondary objectives include progression-free and overall survival, providing early signals of efficacy and durability. All study participants are monitored with regular clinical, lab, and imaging assessments to evaluate safety and potential benefits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent approved by IRB/IEC obtained from subject or legally authorized representative prior to any screening procedures.
2. Age ≥ 18 years and ≤ 70 years at the time of informed consent signing.
3. Diagnosis of acute myeloid leukemia (AML) per 2022 WHO Classification, meeting criteria for relapsed/refractory (R/R) AML as defined in the Chinese Guidelines for the Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2023 Edition): Relapsed AML: Reappearance of leukemic blasts in peripheral blood, bone marrow blasts ≥5%, or extramedullary leukemic infiltration after complete remission (CR). Refractory AML: failure to achieve CR after two cycles of standard induction chemotherapy; early relapse within 12 months post-CR; late relapse with salvage chemotherapy resistance; ≥2 disease relapses or persistent extramedullary disease.
4. Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry.
5. If circulating blasts are detectable at screening, tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry.
6. ECOG performance status 0-2.
7. Expected overall survival \> 3 months.
8. Females of childbearing potential: negative serum pregnancy test and effective contraception for 1 year post-infusion. Males of reproductive potential: effective barrier contraception for 1 year post-infusion and no sperm donation within 1 year after infusion.

Exclusion Criteria:

1. Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent.
2. Severe major organ dysfunction: Renal: eGFR \< 50 mL/min (Cockcroft-Gault); Hepatic: ALT/AST \> 3 × ULN (\>5×ULN if disease-related), total bilirubin \> 2 × ULN (\>3×ULN for Gilbert syndrome); Cardiac: LVEF \< 50%, room air SpO₂ \<94%, uncontrolled severe cardiac disease.
3. Active uncontrolled infection: positive HBsAg/HBV-DNA, active HCV-RNA positivity, HIV positive, positive syphilis antibody, active uncontrolled EBV or CMV viremia.
4. Unstable severe systemic disease requiring continuous medication.
5. Grade \>2 bleeding within 30 days before screening or chronic long-term anticoagulant treatment.
6. Uncontrolled life-threatening bacterial, fungal or viral infection.
7. Non-leukemic central nervous system organic disease or active CNS-2/CNS-3 leukemia; previously treated and resolved CNS leukemia is permitted.
8. Concurrent other malignant tumor except cured in-situ carcinoma or malignancies with ≥5 years continuous complete remission.
9. Live-attenuated vaccines within 30 days before screening or planned within 3 months after CAR-T infusion.
10. Received any other investigational medicinal product within 3 months prior to ICF signature.
11. Allogeneic hematopoietic stem cell transplantation within 6 months before screening.
12. Pregnant or breastfeeding women.
13. Suicidal tendency, ongoing alcohol or illicit drug dependence.
14. Known hypersensitivity to investigational product, excipients or concomitant drugs.
15. Any other condition judged inappropriate for trial entry by investigator.

Where it's running

• Jiangxi Provincial People's Hospital (Participating Site)
  Nanchang, Jiangxi, China Recruiting
• The First Affiliated Hospital of Nanchang University (Lead Site)
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Yu Min
• Email: 625668742@qq.com
• Phone: +86 150 7902 9006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.