- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07598955
Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma (SELECT-NK-THYM)
A Phase 1/2, Open-Label, Target-Selected Study of Allogeneic CAR-NK Cells Directed to CD30, CD5, or Mesothelin in Patients With Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
연구 개요
상태
정황
상세 설명
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Seni S Lu, Phd
- 전화번호: +86 13076790030
- 이메일: Seni-Lu@beijing-biotech.com
연구 장소
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Guangdong
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Shenzhen, Guangdong, 중국, 518036
- 모병
- Peking University Shenzhen Hospital
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연락하다:
- Zhen J Peng, Phd
- 전화번호: +86 13076790039
- 이메일: Zhen-Peng@beijing-biotech.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 to 75 years at the time of consent.
- Histologically confirmed B2 thymoma or thymic carcinoma that is unresectable, metastatic, or recurrent.
- Relapsed or refractory after at least 1 prior systemic therapy (including a platinum-based regimen for thymic carcinoma when appropriate) or no standard curative option available.
- Tumor antigen positivity for at least one of the following by central laboratory assessment: CD30, CD5, or mesothelin. Cohort assignment is based on the dominant target (pre-specified algorithm) and feasibility of manufacturing/availability.
- Measurable disease per RECIST v1.1 (or evaluable disease if measurable disease is not feasible; to be specified).
- ECOG performance status 0-1 (0-2 may be permitted in expansion at investigator discretion).
- Adequate organ function: ANC ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 8 g/dL (transfusions allowed), AST/ALT ≤ 3 x ULN (≤ 5 x ULN with liver involvement), total bilirubin ≤ 1.5 x ULN (except Gilbert's), creatinine clearance ≥ 50 mL/min.
- Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception.
- Ability to understand and sign informed consent.
Exclusion Criteria:
- Active central nervous system involvement by malignancy requiring immediate therapy.
- Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 90 days or unresolved ≥Grade 2 toxicity from prior cellular therapy.
- Uncontrolled infection, including active tuberculosis, or uncontrolled hepatitis B or C infection; known uncontrolled HIV infection.
- Clinically significant autoimmune disease requiring systemic immunosuppression (e.g., >10 mg/day prednisone equivalent) within 14 days of conditioning, except for stable endocrine replacement.
- Prior allogeneic hematopoietic stem cell transplant with active graft-versus-host disease or ongoing immunosuppression.
- Significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction), uncontrolled arrhythmia, or QTc prolongation felt to increase risk.
- Pregnancy or breastfeeding.
- Concurrent participation in another interventional trial with an investigational anticancer agent within 21 days (washout required).
- Any condition that, in the investigator's judgment, would interfere with safe participation or interpretation of results.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cohort A: CD30-CAR-NK
Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
림프구 고갈
림프구 고갈
CD30-targeted allogeneic CAR-NK cells
CD5-targeted allogeneic CAR-NK cells
Mesothelin-targeted allogeneic CAR-NK cells
ctivate the iCasp9 safety switch if clinically indicated
|
|
실험적: Cohort B: CD5-CAR-NK
Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
림프구 고갈
림프구 고갈
CD30-targeted allogeneic CAR-NK cells
CD5-targeted allogeneic CAR-NK cells
Mesothelin-targeted allogeneic CAR-NK cells
ctivate the iCasp9 safety switch if clinically indicated
|
|
실험적: Cohort C: Mesothelin-CAR-NK
Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
림프구 고갈
림프구 고갈
CD30-targeted allogeneic CAR-NK cells
CD5-targeted allogeneic CAR-NK cells
Mesothelin-targeted allogeneic CAR-NK cells
ctivate the iCasp9 safety switch if clinically indicated
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Dose-Limiting Toxicities (DLTs)
기간: 28 Days
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DLTs as defined in protocol, assessed during the DLT window after the first CAR-NK infusion.
Includes severe infusion-related toxicity, Grade >=3 organ toxicity attributable to CAR-NK cells, severe CRS or neurotoxicity, and treatment-related death.
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28 Days
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Recommended Phase 2 Dose
기간: 28 Days
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Determined separately for each cohort based on DLTs, overall safety, and pharmacodynamic data
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28 Days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Response Rate
기간: 12 months
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Proportion of participants with complete response (CR) or partial response (PR) per RECIST v1.1 (or modified criteria appropriate for thymic tumors) in each cohort.
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12 months
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Disease Control Rate
기간: 12 months
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Proportion of participants with CR, PR, or stable disease
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12 months
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- EB-CARNK-THYM-009
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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Taichung Veterans General Hospital완전한심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제대만
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