このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML

2026年5月23日 更新者:Xiangyu Zhao、Peking University People's Hospital

A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed/Refractory Acute Myeloid Leukemia

A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, efficacy, and cellular pharmacokinetics of CT0890B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 12~27 participants in this trial.

研究の種類

介入

入学 (推定)

27

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

      • Beijing、中国、100044
        • 募集
        • Peking University People's Hospital
        • 副調査官:
          • Meng Lv, M.D, Ph.D
        • コンタクト:
        • 主任研究者:
          • Xiangyu Zhao, M.D, Ph.D

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. Age 18-70 years (inclusive), male or female.
  2. Relapsed or refractory acute myeloid leukemia (R/R AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.
  3. Bone marrow blasts ≥5% by morphology.
  4. Estimated life expectancy >12 weeks.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  6. Adequate organ function without ongoing supportive care, defined as:

    1. Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
    2. Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;
    3. Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
    4. Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.

    c) Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula); d) Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.

Exclusion Criteria:

  1. Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;
  2. Participants with a history of epilepsy or other central nervous system disease;
  3. Participants who have previously received autologous or allogeneic CAR-T therapy;
  4. Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
  5. Participants who have received prior immunotherapy targeting NKG2DL;
  6. Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;
  7. Participant has any of the following at screening:

1)Active, uncontrolled systemic infection or requiring intravenous anti-infective agents 2)Any of the following cardiac conditions, including:

  1. New York Heart Association Class III-IV heart failure;
  2. History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;
  3. History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
  4. History of severe nonischemic ardiomyopathy;
  5. Other cardiac disease that the investigatorbelieve could jeopardize the participant 's well-being or compromise participation in this clinical trial; 3) Active bleeding of clinical significance as judged by the investigator; 4)Requiring supplemental oxygen to maintain oxygen saturation> 92%; 5)Patients with severe chronic obstructive pulmonary disease (COPD) or other lung diseases that cannot tolerate CAR-T treatment as judged by the 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:単一グループの割り当て
  • 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:CAR-T cells chimeric antigen receptor T cells
CT0890B cells infusion

Conditioning regimen:

Days -9 to -3:

Venetoclax administered with a target dose of 200 mg/day.

Days -5 to -4:

Cytarabine administered at 500 mg/m²/day.

Days -5 to -3:

Cyclophosphamide at 300 mg/m²/day plus Fludarabine at 30 mg/m²/day.

Day 0:

Infusion of CT0890B CAR-T cells at one of four dose levels using an i3+3 Dose-Escalation Design:

1.5 × 10⁸ total cells, 3.0 × 10⁸ total cells, 4.5 × 10⁸ total cells, 6.0 × 10⁸ total cells

他の名前:
  • Off-the-shelf allogeneic 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
Adverse Events (AE) after CT0890B infusion
時間枠:12 months after CT890B infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
12 months after CT890B infusion
Dose-limiting toxicity (DLT)
時間枠:Up to 28 days after CAR-T cells infusion
The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0890B that meet the criteria for DLT events after the first infusion
Up to 28 days after CAR-T cells infusion
MTD and/or dose range
時間枠:Up to 28 days after CAR-T cells infusion
Evaluate Dose limited toxicity and recommended dosage range after CT0890B infusion
Up to 28 days after CAR-T cells infusion

二次結果の測定

結果測定
メジャーの説明
時間枠
Composite response (CRc)
時間枠:12 months after CT0890B infusion
The composite response rate (CRc) included complete response (CR), complete response with partial hematologic recovery (CRh), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS). Responses were assessed in accordance with the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet criteria for acute myeloid leukemia (AML).
12 months after CT0890B infusion
Partial response (PR)
時間枠:12 months after CT0890B infusion
Partial response (PR) was defined and assessed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet response criteria for AML.
12 months after CT0890B infusion
Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy
時間枠:12 months after CT0890B infusion
This secondary endpoint was defined as the proportion of patients who proceeded to stem cell transplantation after CAR-T therapy during the study period.
12 months after CT0890B infusion
Duration of response (DOR)
時間枠:12 months after CT0890B infusion
Patients achieving CR, CRi, CRh, or MLFS were included in the duration of response (DOR) analysis set. DOR was defined as the time from the date of first documented response to the date of disease relapse or death from any cause, whichever occurred first.
12 months after CT0890B infusion
Event-free survival (EFS)
時間枠:12 months after CT0890B infusion

EFS was defined as the time from the date of CAR-T infusion to the earliest occurrence of treatment failure, relapse, or death from any cause. Treatment failure was defined as failure to achieve CR, CRh, CRi, MLFS, or PR at both prespecified efficacy assessments. Relapse included hematologic or extramedullary relapse after achieving CR, CRh, CRi or MLFS.

For patients with treatment failure (ineffective therapy), the primary EFS analysis assigned an event time of 1 day (i.e., the time from infusion to treatment receipt). Sensitivity analyses were performed using alternative definitions of event timing, including the actual date of treatment failure, the end of treatment, or the initiation of subsequent anti-leukemia therapy.

12 months after CT0890B infusion
Overall survival (OS)
時間枠:12 months after CT0890B infusion
OS is defined as the time from the date of receiving the infusion to the date of death from any cause.
12 months after CT0890B infusion
Minimal Residual Disease (MRD) Negativity Rate
時間枠:12 months after CT0890B infusion
MRD negativity rate was assessed in participants who achieved CR, CRh, CRi or MLFS. MRD negativity was defined as <0.01% abnormal cells among CD45-positive cells as determined by multiparameter flow cytometry (MFC).
12 months after CT0890B infusion
Pharmacokinetic Endpoint - Peak expansion (Cmax)
時間枠:12 months after CT0890B infusion
The maximum concentration or peak value of CT0890B cells in plasma after infusion, measured by CAR copy number.
12 months after CT0890B infusion
Time to peak expansion (Tmax) of CT0890B
時間枠:12 months after CT0890B infusion
The time required to reach the peak expansion (maximum CAR copy number) in plasma following the infusion of CT0890B cells.
12 months after CT0890B infusion
Area under the curve (AUC) of CT0890B
時間枠:12 months after CT0890B infusion
The total cellular exposure in plasma after infusion, calculated based on the area under the CAR copy number-time curve.
12 months after CT0890B infusion
In vivo persistence of CT0890B
時間枠:Up to 12 months after CT0890B infusion
The duration for which CT0890B cells remain detectable in the plasma after infusion, monitored via CAR copy number.
Up to 12 months after CT0890B infusion

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

協力者

捜査官

  • 主任研究者:XiangYu Zhao, M.D, Ph.D、Peking University People's Hospital

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 (推定)

2026年5月7日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年5月1日

QC基準を満たした最初の提出物

2026年5月23日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月1日

QC基準を満たした最後の更新が送信されました

2026年5月23日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CT0890B-CG8001

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?

未定

医薬品およびデバイス情報、研究文書

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。