NCT05993299已完成2 期
Evaluation of Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 38
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
- •Participant scheduled to receive clinical drug product supply must also weigh ≥40 kg
- •Participant must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles by a designated central laboratory
- •Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory.
- •Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
- •Performance status: dependent on age - Lansky > 60, Karnofsky > 60, Eastern
- •Cooperative Oncology Group 0-
- •Participant must have adequate organ function and blood cell counts, within 7 days prior to leukapheresis.
- •At time of treatment, participant has measurable disease according to RECIST v1.
- •Male or female. Contraception requirements will apply at the time of leukapheresis and treatment.
- •Consultation for prior history per protocol specifications.
排除标准
- •Central nervous system metastases.
- •Any other prior malignancy that is not in complete remission.
- •Clinically significant systemic illness (.(Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the participant's ability to tolerate protocol therapy or significantly increase the risk of complications)
- •Prior or active demyelinating disease.
- •History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments.
- •Previous treatment with genetically engineered NY-ESO-1-specific T cells.
- •Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
- •Prior gene therapy using an integrating vector.
- •Previous allogeneic hematopoietic stem cell transplant.
- •Washout periods for prior radiotherapy and systemic chemotherapy must be followed.
- •Participant had major surgery in less than or equal to 28 days of first dose of study intervention.
- •Prior radiation exceeds protocol specified limits.
研究组 & 干预措施
Letetresgene autoleucel
Experimental
干预措施: Letetresgene autoleucel (Drug)
Letetresgene autoleucel
Experimental
干预措施: Cyclophosphamide (Drug)
Letetresgene autoleucel
Experimental
干预措施: Fludarabine (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to approximately 36 months
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). 95% CI is based on Clopper-Pearson exact confidence interval.
次要结局
- Time to Cmax (Tmax)(Day 1 to Day 14)
- Time to Response (TTR)(Up to approximately 54 months)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Up to approximately 54 months)
- Area Under the Time Curve From Zero to Time 28 Days (AUC[0-28])(Up to 28 days)
- Percentage of Participants With Replication Competent Lentivirus (RCL) Positive(Up to approximately 54 months)
- Instances of Insertional Oncogenesis (IO)(Up to approximately 54 months)
- Duration of Response (DOR)(Up to approximately 54 months)
- Number of Participants With AESIs by Severity(Up to approximately 54 months)
- Disease Control Rate (DCR)(Up to approximately 36 months)
- Progression Free Survival (PFS)(Up to approximately 54 months)
- Number of Participants With AEs of Special Interest (AESIs)(Up to approximately 54 months)
- Number of Participants With TEAEs and TESAEs by Severity(Up to approximately 54 months)
- Maximum Transgene Expansion (Cmax)(Day 1 to Day 14)
研究者
研究点 (38)
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