NL-OMON52650已完成不适用
Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, alone or in combination with other agents, in Participants with Advanced Tumors (study 209012) - 209012
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •SUBSTUDY 1:
- •Male or female, age 18 years and above.
- •Measurable disease (RESIST v1.1).
- •Tumor sample plus report is available for NY-ESO-1 analysis. See protocol
- •section 6.1.1 item 3.
- •Synovial sarcoma and myxoid/round cell liposarcoma:
- •Diagnosis of synovial sarcoma or myxoid/round cell liposarcoma confirmed by
- •local histology and with evidence of disease-specific translocation.
- •Advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell
- •liposarcoma. See protocol section 6.1.1 for details.
- •Histologically or cytologically confirmed Stage IV NSCLC.
- •LEUKAPHERESIS:
- •HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive and NY-ESO-1 positive.
- •See protocol section 6.1.2 item 8-9.
- •Measurable disease (RECIST v1.1).
- •For sarcoma: Has completed at least one standard of care treatment including
- •anthracycline
- •containing regimen OR is intolerant to the therapy. See protocol section 6.1.2,
- •For NSCLC: Has been previously treated with or is intolerant to PD-1/PD-L1
- •checkpoint blockade therapy and a platinum-based chemotherapy, or is intolerant
- •to it. See protocol section 6.1.2, item 13 and 14.
- •Left ventricular ejection fraction >=45%. See protocol section 6.1.2 item 15.
- •ECOG performance status 0-1.
- •Adequate organ function (see protocol Table 9).
- •Contraception guidelines for males and females should be followed, see
- •chapter 6.1.2 item 19 of the protocol for details.
- •Negative pregnancy test for female participants able to become pregnant.
- •Documented radiographic evidence of disease progression from prior line of
- •A biopsy of non-target tumor tissue obtained within 28 days prior to
- •initiating the chemotherapy is mandatory. See protocol section 6.1.3 item 23
- •for details.
- •For a detailed list of Iclusion Critera, please refer to the protocol for
- •substudy 1 (page 54-59).
- •Male or female, age 18 years and above.
- •Tumor sample plus report is available for NY-ESO-1 analysis. See protocol
- •section 6.1.1 item 3.
- •Diagnosis of synovial sarcoma or myxoid/round cell liposarcoma confirmed by
- •local histology. and with evidence of disease-specific translocation.
- •Advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell
- •liposarcoma. See protocol section 6.1.1 for details.
- •LEUKAPHERESIS:
- •HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive and NY-ESO-1 positive.
- •See protocol section 6.1.2 item 7.
- •Measurable disease (RECIST v1.1).
- •Evidence of radiographic or clinical disease progression.
- •Has completed at least one standard of care treatment including anthracycline
- •containing regimen OR is intolerant to the therapy. See protocol section 6.1.2,
- •Left ventricular ejection fraction >=45%. See protocol section 6.1.2 item 15.
- •ECOG performance status 0-1.
- •Adequate organ function (see protocol Table 10).
- 另有 6 项未显示
排除标准
- •SUBSTUDY 1:
- •CNS metastases. See protocol section 6.2.2 item 6 for exceptions.
- •Clinically significant systemic illness, see protocol section 6.2.1, item 2
- •for details.
- •Previous treatment with genetically engineered NY-ESO-1-specific T cells
- •NY-ESO-1 vaccine or NY-ESO-1 targeting antibody. See protocol section 6.2.1
- •Prior gene therapy using an integrating vector. See protocol section 6.2.1
- •Prior allogeneic hematopoietic stem cell transplant within the last 5 years
- •or solid organ transplant.
- •LEUKAPHERESIS:
- •CNS metastases. See protocol section 6.2.2 item 6.
- •History of chronic or recurrent (within the last year prior to leukapheresis)
- •severe autoimmune or immune mediated disease requiring steroids or other
- •immunosuppressive treatments.
- •Uncontrolled intercurrent illness. See protocol chapter 6.2.2, item 9 for
- •Insufficient pulmonary function with mechanical parameters <40% predicted.
- •See protocol chapter 6.2.2, item 12 for details
- •Current active liver or biliary disease. See protocol chapter 6.2.2, item 11
- •for details.
- •QTc >480 msec. See protocol chapter 6.2.2, item 12 for details.
- •Active infections. See protocol chapter 6.2.2, item 14 for details.
- •NSCLC: Radiotherapy that involves the lung or bone marrow exposure or heart
- •exposure. See protocol chapter 6.2.2, item 18 for criteria and other details.
- •Cytotoxic therapy within the last 3 weeks prior to chemotherapy.
- •Systemic corticosteroids or any other immunosuppressive therapy within the
- •last 2 weeks prior to chemotherapy. See protocol chapter 6.2.3, item 23 for
- •>=50 Gy to a significant volume of the pelvis, long bones or
- •spine. See protocol section 6.2.3 item 20.
- •Radiotherapy to the target lesions within the last 3 months. See protocol
- •chapter 6.2.3, item 24 for details.
- •Anti-cancer vaccine within the last 2 months prior to chemotherapy in the
- •absence of tumor response. See protocol chapter 6.2.3, item 23 for details.
- •Live vaccine within the last 4 weeks prior to chemotherapy.
- •Immune therapy within the last 4 weeks prior to chemotherapy. See protocol
- •chapter 6.2.3, item 25 for details.
- •Washout periods for prior therapy see protocol chapter 6.2.3, Table 10.
- •For a detailed list of Exclusion Criteria please refer to the Substudy 1
- •protocol (Page 60-65).
- •SUBSTUDY 2:
- •Any other prior malignancy that is not in complete remission. See protocol
- •section 6.2.1 item 1 for exceptions.
- •Clinically significant systemic illness, see protocol section 6.2.1, item 2
- •for details.
- •Previous treatment with genetically engineered NY-ESO-1-specific T cells
- •NY-ESO-1 vaccine or NY-ESO-1 targeting antibody. See protocol section 6.2.1
- •Prior gene therapy using an integrating vector. See protocol section 6.2.1
- •Prior allogeneic hematopoietic stem cell transplant within the last 5 years
- •or solid organ transplant.
- •LEUKAPHERESIS:
- •CNS metastases.
- 另有 5 项未显示
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