- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02958384
A Clinical Research of LeY-Targeted CAR-T in Myeloid Malignancies
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Chongqing
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Chongqing, Chongqing, 중국, 400000
- 모병
- Southwest Hospital of Third Millitary Medical University
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연락하다:
- Zhi Yang, PhD
- 전화번호: 008613206140093
- 이메일: Lystch@qq.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- LeY-expressing myeloid malignancy must be assured and must be relapsed or refractory disease. According to current traditional therapies, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have disease activity that prohibits SCT at this time.
- Patients enrolled must have an evaluated score above 60 with KPS.
- LeY expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
- Gender is not limited, age from 14 years to 75 years.
- Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
- Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
- Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts.
Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:
CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs; CNS 2, defined as presence of < 5/uL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm CNS3 with marrow disease who has failed salvage systemic and intensive IT chemotherapy (and therefore not eligible for radiation)
- Ability to give informed consent.
- Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
- Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
- Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
- Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- Patients volunteer to participate in the research.
Exclusion Criteria:
- Evident signs suggesting that patients are potentially allergic to cytokines.
- Frequent infection history and recent infection is uncontrolled.
- Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
- Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
- Pregnancy and nursing females.
- HIV infection.
- Active hepatitis B or active hepatitis C.
- Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
- Other situations we think not eligible for participation in the research.
공부 계획
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 |
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실험적: Myeloid Malignancies
The trial will be conducted in a manner of simon two-stage design with Anti-LeY-CAR-transduced T cells, beginning in the first stage with the aim of over 30% reaction rate among 15 patients with myeloid malignancies.
Only when the expected reaction rate is achieved the 30 patients left can be recruited.
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The first 3 enrolled patients will receive autologous-derived LeY-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy.
If the 3 patients don't display severe toxicity,the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adverse Events That Are Related to Treatment
기간: 3 years
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Determine the toxicity profile of the LeY targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
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3 years
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2차 결과 측정
결과 측정 |
기간 |
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치료 반응률
기간: 3 년
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3 년
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In vivo existence of Anti-LeY CAR-T cells
기간: 3 years
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3 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Cheng Qian, MD, PhD, Biotherapy Center of Southwest Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Anti-LeY-CAR-transduced T cells에 대한 임상 시험
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Peter MacCallum Cancer Centre, Australia완전한
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Zhejiang UniversityUTC Therapeutics Inc.모병
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Thomas Martin, MDUniversity of California, Davis; Actavis Inc.; Eugia Pharma Specialities Limited모집하지 않고 적극적으로
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M.D. Anderson Cancer CenterInvectys모병
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Jonsson Comprehensive Cancer CenterParker Institute for Cancer Immunotherapy모병재발성 맨틀 세포 림프종 | 재발성 소림프구성 림프종 | 재발성 미만성 대형 B세포 림프종 | 난치성 미만성 대형 B세포 림프종 | 난치성 만성 림프 구성 백혈병 | CD20 포지티브 | 난치성 맨틀 세포 림프종 | 재발성 만성 림프 구성 백혈병 | 난치성 소림프구성 림프종 | 재발성 여포성 림프종 | 난치성 여포성 림프종 | CD19 양성 | 재발성 원발성 종격동(흉선) 대형 B세포 림프종 | 난치성 원발성 종격동(흉선) 대형 B세포 세포 림프종미국