Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

NCT07668557 | Recruiting Phase 1

• 1 other identifier: ICG415-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute Myeloid Leukemia; AML; Leukemia; Acute Leukemia; Myeloid Leukemia; CAR-T; Cellular Therapy; CD33-CLL1 CAR-T; Relapsed or Refractory; R/R AML

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLTs)

  DLTs assessed according to the protocol-defined criteria.

  Within 28 days after ICG415 CAR-T cell infusion

• Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

  Frequency and severity of TEAEs graded by NCI-CTCAE Version 5.0, including changes from baseline in vital signs, physical examination, 12-lead ECG, and clinical laboratory parameters (complete blood count, urinalysis, blood chemistry, coagulation function, etc.).

  From first dose through 24 months post infusion

Secondary Outcomes (11)

• Objective Response Rate (ORR) at Months 1, 3, and 6

  Month 1, Month 3, Month 6

• Rates of CR, CRi, and PR at Year 1 and Year 2

  Year 1, Year 2

• Cumulative Incidence of Relapse (CIR) at Year 1 and Year 2

  Year 1, Year 2

• Duration of Response (DOR)

  From first documented response to disease relapse or death from any cause, assessed up to 24 months

• Progression-Free Survival (PFS)

  From date of infusion to disease progression or death from any cause, assessed up to 24 months

Study Arms (1)

Single Arm, Anti-CD33-CLL1 CAR-T (ICG415) for Relapsed or Refractory AML

EXPERIMENTAL

Biological: Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide

Interventions

Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide BIOLOGICAL

Anti-CD33, Anti-CLL1 Compound CAR-T Cells

Single Arm, Anti-CD33-CLL1 CAR-T (ICG415) for Relapsed or Refractory AML

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent.
• 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.
• 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.
• Grade \>2 bleeding within 30 days before screening or chronic long-term anticoagulant treatment.
• Uncontrolled life-threatening bacterial, fungal or viral infection.
• 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.
• Pregnant or breastfeeding women.
• Suicidal tendency, ongoing alcohol or illicit drug dependence.
• Known hypersensitivity to investigational product, excipients or concomitant drugs.
• Any other condition judged inappropriate for trial entry by investigator.

Sponsors & Collaborators

• iCell Gene Therapeutics: lead

Study Sites (2)

Jiangxi Provincial People's Hospital (Participating Site)

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Affiliated Hospital of Nanchang University (Lead Site)

Nanchang, Jiangxi, 330006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia; Leukemia, Myeloid; Recurrence

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Yu Min

CONTACT

+86 150 7902 9006; 625668742@qq.com

Li Fei

CONTACT

+86 139 7003 8386; yx021021@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): July 4, 2028
• Study Completion (Estimated): July 4, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)