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Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (ICG415-AML-01)

2026年6月19日 更新者：iCell Gene Therapeutics

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Acute myeloid leukemia (AML) is an aggressive hematologic malignancy with limited treatment options for patients who are relapsed or refractory (R/R) to standard therapies. Leukemic blasts in R/R AML frequently co-express CD33 and CLL1, while sparing normal hematopoietic stem cells, making them rational targets for chimeric antigen receptor (CAR) T-cell therapy.

This phase I, single-arm, open-label study evaluates ICG415 CAR-T Cells in patients with R/R AML. After leukapheresis and ex vivo modification, patients receive a single CAR-T cell infusion following lymphodepleting chemotherapy with fludarabine and cyclophosphamide. Primary objectives are safety and tolerability, including dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), and neurological events. Secondary objectives include response rate (CR/CRi/PR), minimal residual disease (MRD) negativity, progression-free survival (PFS), and overall survival (OS).

All participants will be followed for up to 24 months with regular clinical, laboratory, and imaging evaluations to monitor both treatment efficacy and potential complications.

研究の種類

介入

入学 (推定)

18

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
    • Jiangxi
      • Nanchang、Jiangxi、中国、330006
        • 募集
        • Jiangxi Provincial People's Hospital (Participating Site)
        • コンタクト：
      • Nanchang、Jiangxi、中国、330006
        • 募集
        • The First Affiliated Hospital of Nanchang University (Lead Site)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Single Arm, Anti-CD33-CLL1 CAR-T (ICG415) for Relapsed or Refractory AML
生物学的：Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide
Anti-CD33, Anti-CLL1 Compound CAR-T Cells

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Dose-Limiting Toxicities (DLTs)
時間枠：Within 28 days after ICG415 CAR-T cell infusion
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)
時間枠：From first dose through 24 months post infusion
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) at Months 1, 3, and 6
時間枠：Month 1, Month 3, Month 6
ORR defined as proportion of subjects achieving complete remission (CR), complete remission with incomplete count recovery (CRi), or complete remission with partial hematological recovery (CRh) per response criteria.
Month 1, Month 3, Month 6
Rates of CR, CRi, and PR at Year 1 and Year 2
時間枠：Year 1, Year 2
Proportion of subjects achieving complete remission (CR), complete remission with incomplete count recovery (CRi), and partial remission (PR) at 1 and 2 years post infusion.
Year 1, Year 2
Cumulative Incidence of Relapse (CIR) at Year 1 and Year 2
時間枠：Year 1, Year 2
Cumulative incidence of disease relapse at 1 and 2 years after CAR-T cell infusion.
Year 1, Year 2
Duration of Response (DOR)
時間枠：From first documented response to disease relapse or death from any cause, assessed up to 24 months
Time from first objective response (CR, CRi, or CRh) to relapse or death, whichever occurs first.
From first documented response to disease relapse or death from any cause, assessed up to 24 months
Progression-Free Survival (PFS)
時間枠：From date of infusion to disease progression or death from any cause, assessed up to 24 months
Time from ICG415 infusion to disease progression (relapse or treatment failure) or death from any cause.
From date of infusion to disease progression or death from any cause, assessed up to 24 months
Overall Survival (OS)
時間枠：From date of infusion to death from any cause, assessed up to 24 months
Time from ICG415 infusion to death from any cause.
From date of infusion to death from any cause, assessed up to 24 months
Event-Free Survival (EFS)
時間枠：From date of infusion to any treatment failure, relapse, or death, assessed up to 24 months
Time from ICG415 infusion to any event including lack of response, disease relapse, or death from any cause.
From date of infusion to any treatment failure, relapse, or death, assessed up to 24 months
CAR-T Cell Kinetics - Persistence over Time
時間枠：Days 0, 4, 7, 14, 21, 28; Months 2, 3, 6, 9, 12, 18, 24
Number and duration of detectable CAR-T cells in peripheral blood. Testing stops after two consecutive negative results.
Days 0, 4, 7, 14, 21, 28; Months 2, 3, 6, 9, 12, 18, 24
Cytokine Level Changes
時間枠：Days 0, 7, 14, 21, 28; Months 2, 3, 6
Changes in serum cytokine levels including IL-6, IL-10, IL-15, TNF-α, and IFN-γ.
Days 0, 7, 14, 21, 28; Months 2, 3, 6
Peripheral Blood Lymphocyte Subset Changes
時間枠：Days 0, 7, 14, 21, 28; Months 2, 3, 6
Changes in lymphocyte subsets including T cells, B cells, NK cells, and CD4/CD8 ratio measured by flow cytometry.
Days 0, 7, 14, 21, 28; Months 2, 3, 6
Anti-Drug Antibody (ADA) Levels
時間枠：Day 28; Months 3, 6, 12
Incidence and titers of anti-drug antibodies (ADA) against ICG415 CAR-T cells.
Day 28; Months 3, 6, 12

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

iCell Gene Therapeutics

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月10日

一次修了 (推定)

2028年7月4日

研究の完了 (推定)

2029年7月4日

試験登録日

最初に提出

2026年6月19日

QC基準を満たした最初の提出物

2026年6月19日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年6月19日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ICG415-001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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