NCT07668557 Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
| NCT ID | NCT07668557 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | iCell Gene Therapeutics |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-06-10 |
| Primary Completion | 2028-07-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2026-06-10 with a primary completion date of 2028-07-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07668557 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07668557 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07668557 currently recruiting?
Yes, NCT07668557 is actively recruiting participants. Contact the research team at 625668742@qq.com for enrollment information.
Where is the NCT07668557 trial being conducted?
This trial is being conducted at Nanchang, China, Nanchang, China.
Who is sponsoring the NCT07668557 clinical trial?
NCT07668557 is sponsored by iCell Gene Therapeutics. The trial plans to enroll 18 participants.
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