Tests CAR-T cells targeting CD33 and CLL1 in relapsed acute myeloid leukemia
Tests ICG415 CAR-T cells in adults with relapsed or refractory acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Nanchang, ChinaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with acute myeloid leukemia that came back or did not respond to treatment, and whose leukemia cells carry both CD33 and CLL-1.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia that has relapsed or did not respond to treatment (relapsed or refractory). Daily-life ability score (ECOG) of 0 to 2 and expected survival of more than 3 months.
- Earlier treatment
- Must not have had CAR-T or other genetically modified cell therapy. Must not have had a stem cell transplant from a donor within 6 months. Must not have had another investigational drug within 3 months.
- Biomarker or test result
- Bone marrow leukemia cells must be positive for both CLL-1 and CD33. If leukemia cells are in the blood, they must be CD4 and CD8 double-negative.
Main reasons for not taking part
- Serious kidney, liver or heart problems
- Active uncontrolled infection, including HIV, hepatitis B or hepatitis C
- Active leukemia in the central nervous system
- Another cancer at the same time (with some exceptions)
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07668557, who can take part
Where in China
- Jiangxi Provincial People's Hospital (Participating Site)Nanchang, ChinaTaking people
- The First Affiliated Hospital of Nanchang University (Lead Site)Nanchang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- iCell Gene Therapeutics
- Trial code
- NCT07668557
- Record updated
- 25 June 2026
- Original description
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.Read full original descriptionShow less
A Clinical Study to Evaluate the Safety and Efficacy of ICG415 CAR-T Cells in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
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.
Inclusion: Written informed consent approved by IRB/IEC obtained from subject or legally authorized representative prior to any screening procedures; Age ≥ 18 years and ≤ 70 years at the time of informed consent signing; 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; Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry; If circulating blasts are detectable at screening, tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry; ECOG performance status 0-2; Expected overall survival > 3 months; 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: Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent; Grade >2 bleeding within 30 days before screening or chronic long-term anticoagulant treatment; Non-leukemic central nervous system organic disease or active CNS-2/CNS-3 leukemia; previously treated and resolved CNS leukemia is permitted; Concurrent other malignant tumor except cured in-situ carcinoma or malignancies with ≥5 years continuous complete remission; Live-attenuated vaccines within 30 days before screening or planned within 3 months after CAR-T infusion; Received any other investigational medicinal product within 3 months prior to ICF signature; Allogeneic hematopoietic stem cell transplantation within 6 months before screening; Suicidal tendency, ongoing alcohol or illicit drug dependence; Known hypersensitivity to investigational product, excipients or concomitant drugs; Active uncontrolled infection: positive HBsAg/HBV-DNA, active HCV-RNA positivity, HIV positive, positive syphilis antibody, active uncontrolled EBV or CMV viremia; Unstable severe systemic disease requiring continuous medication; Uncontrolled life-threatening bacterial, fungal or viral infection; Any other condition judged inappropriate for trial entry by investigator; 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; Pregnant or breastfeeding women.