Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) - Assessment of safety & antitumor activity of GSK3377794 in NY-ESO-1+ and/or LAGE-1a+ solid tumors

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 65 人开始时间: 2021年6月4日最近更新: 2021年8月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 65

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Subject must be >=10 years of age at the time of signing the informed consent.
•- Participant enrolled under clinical drug product supply must also weigh =40 kg.
•- Subject has a diagnosis of synovial sarcoma confirmed by histology.
•- Subject has advanced (metastatic or unrespectable) synovial sarcoma.
•- In substudy 1, subject with metastatic synovial sarcoma who is newly diagnosed or previously untreated
•- In substudy 2, at the time of treatment, subject has received/completed treatment with anthracycline or anthracycline with ifosfamide for advanced (metastatic or inoperable) disease and progressed.
•- Male or female. Contraception requirements will apply at the time of leukapheresis and treatment.
•- An archival sample from most recent biopsy or fresh biopsy (if collected as part of standard of care) of tumor tissue should be available to perform NY-ESO-1 antigen expression analysis
•- All the Inclusion Criteria in 1-7 must apply again prior to leukapheresis.
•- Subject must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles by a validated test in a designated central laboratory.
•- Subjects tumor has been pathologically reviewed by a designated central laboratory with confirmed positive NY-ESO-1 expression
•- Performance status: Eastern Cooperative Oncology Group of 0-1.
•- Participant must have adequate organ function and blood cell counts, 7 days prior to procedure, as indicated by the following laboratory values in Table 4 in the protocol.
•- Subject must have adequate organ function and blood cell counts 7 days prior to leukapheresis.
•- Female subjects of childbearing potential must have a negative urine or serum pregnancy test.
•- Subject has measurable disease according to RECIST v1.1.
•- Supportive radiotherapy has not affected >25% of bone marrow.
•-A biopsy (excisional, incisional, or core) of non-target tumor tissue obtained within 28 days prior to initiating lymphodepleting chemotherapy is mandatory. If it is not feasible to obtain a fresh biopsy, an archival tumor tissue (FFPE block) taken after completion of the participant's last line of therapy, preferably within 90 days prior to initiating lymphodepleting chemotherapy, may be accepted at the
•discretion of the Medical Monitor (or designee). This biopsy will be used as baseline for biomarker analyses.
•For a detailed list of Inclusion Criteria's please refer to the protocol
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

排除标准

•- In substudy 1, subject has been previously treated for metastatic synovial sarcoma.
•Central nervous system metastases.
•- Any other prior malignancy that is not in complete remission.
•- 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.
•- 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 subject’s ability to tolerate protocol therapy or significantly increase the risk of complications, or, prior or active demyelinating disease.
•- Participants are not eligible for leukapharesis if any of the Exclusion criteria 1-8 apply.
•Please note in particular that mandatory washout period restrictions must be respected (Table 5) before starting leukapheresis. In addition, participants are not eligible for leukapharesis if any of the following criteria apply.
•- Subject has 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
•- Current active liver or biliary disease.
•- Pregnant or breastfeeding females (due to risk to fetus or newborn).
•- Prior/concomitant therapy: any prior treatment-related toxicities must be Common terminology criteria for adverse events <=Grade 1 at the time of initiating study intervention (except for non-clinically significant toxicities).
•- Other standard of care lines of therapy are allowed only if guidelines and washout periods are followed.
•- Subject has active infection as defined in the protocol
•- Subject has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.
•- Subject had major surgery <=28 days of first dose of study intervention.
•- Participant has received live vaccine within 4 weeks prior to lymphodepletion or intends to receive live vaccine during the 3 month period following administration of GSK3377794.
•For a detailed list of Exclusion Criteria's please refer to the Protocol

研究者

发起方

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT

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