- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04677452
Dose Exploration Study OF JWCAR129, BCMA-Targeted CART for RRMM
An Open-Label Phase 1 Dose Exploration Study of JWCAR129, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma
연구 개요
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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Jiangsu
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Suzhou, Jiangsu, 중국, 215000
- 모병
- First Affiliated Hospital, SooChow University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years old and above.
- Signed the Informed Consent Form.
Diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen). Subjects must be refractory to the last anti-myeloma treatment regimen prior to entering the study.
- Autologous hematopoietic stem cell transplantation.
- A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or in combination. Subjects must have undergone at least 2 consecutive cycles of treatment for each regimen unless progressive disease was the best response to the regimen.
- Anti-CD38 (eg, daratumumab) as part of a combination regimen or as a monotherapy.
Subjects who were not candidates to receive one or more of the above treatments (ie, contraindicated) are eligible; the reason for not receiving treatment must be clearly documented in the case report form.
- Subjects must have measurable disease.
- Subject must be willing to provide fresh bone marrow biopsy samples during Screening (and prior to study treatment, if required).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
- Subjects with known active or history of CNS involvement by malignancy
- Subjects with solitary plasmacytoma; active or history of plasma cell leukemia (PCL); Waldenstrom's macroglobulinemia; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasmaproliferative disorder, Skin changes (POEMS) syndrome; or symptomatic amyloidosis
- History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.
- Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R])
- Prior CAR T-cell or other genetically-modified T-cell therapy
- Prior treatment with a BCMA-targeted agent
- History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Untreated or active infection at time of initial screening, at the time of leukapheresis, within 72 hrs before lymphodepletion, or 5 days before JWCAR129 infusion.
- History of any of the following cardiovascular conditions within 6 months of initial screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease
- History of severe immediate hypersensitivity reaction to any of the protocol-mandated or recommended agents used in this study
- Allogeneic hematopoietic stem cell transplantation.
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: JWCAR129
Subjects will receive a course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single dose of JWCAR129
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Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR129.
During JWCAR129 production, participants may receive bridging chemotherapy for disease control.
Following successful generation of JWCAR129 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JWCAR129 administered intravenously (IV).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of dose-limiting toxicities (DLTs)
기간: 28 days
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Proportion of subjects with adverse events meeting DLT criteria
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28 days
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Incidence and severity of adverse events
기간: 2 years
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Proportion of subjects with adverse events overall and by severity grade
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2 years
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Incidence and severity of clinically significant laboratory abnormalities
기간: 2 years
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Proportion of subjects with clinically significant laboratory abnormalities overall and by severity grade
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Cmax
기간: 2 years
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Maximum concentration (Cmax) of JWCAR129 in the blood
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2 years
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Tmax
기간: 2 years
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Time to maximum concentration (Tmax) of JWCAR129 in the blood
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2 years
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AUC
기간: 2 years
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Area under the concentration vs time curve (AUC) of JWCAR129 in the blood
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2 years
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Duration of persistence
기간: 2 years
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Duration of persistence of JWCAR129 CAR T cells in the blood
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2 years
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Overall response rate
기간: 2 years
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Proportion of subjects with a partial response (PR) or better by IMWG criteria
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2 years
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CR rate
기간: 2 years
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Proportion of subjects with a CR by IMWG criteria
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2 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- JWCAR129
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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