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

2026년 5월 23일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

27

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Beijing, 중국, 100044
        • 모병
        • Peking University People's Hospital
        • 부수사관:
          • Meng Lv, M.D, Ph.D
        • 연락하다:
        • 수석 연구원:
          • Xiangyu Zhao, M.D, Ph.D

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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;

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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

다른 이름들:
  • Off-the-shelf allogeneic CAR-T cells

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Adverse Events (AE) after CT0890B infusion
기간: 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)
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Composite response (CRc)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: XiangYu Zhao, M.D, Ph.D, Peking University People's Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 7일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 5월 23일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 23일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CT0890B-CG8001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

AML에 대한 임상 시험

CAR-T cells chimeric antigen receptor T cells에 대한 임상 시험

구독하다