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临床试验/EUCTR2018-003949-42-NL
EUCTR2018-003949-42-NL进行中（未招募）1 期

A Phase 1b/2a Pilot Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T-Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination with Pembrolizumab in HLA-A2+ Participants with NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer - Pilot immunotherapy study with GSK3377794 (NY-ESO T-cells) in NSCLC patients.

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 54 人开始时间: 2019年7月30日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
54
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

  • •Inclusion/Exclusion criteria are grouped into 4 parts and eligibility screening will take place in the following 4 steps:
  • •-Target expression screening:
  • •A set of criteria permitting participants’ blood to be screened for HLA-type and tumor sample to be screened for the expression of NYESO-1/LAGE-1A.
  • •-Leukapheresis eligibility screening: To be fulfilled prior to performing leukapheresis procedure.
  • •-Lymphodepletion eligibility screening: To be fulfilled prior to performing lymphodepletion procedure.
  • •-Treatment fitness: To be evaluated prior to commencing lymphodepleting chemotherapy and administration of
  • •-Pembrolizumab treatment screening (Arm A ONLY, Part 4): To be fulfilled prior to commencing pembrolizumab treatment among patients in Arm A who progress following administration of lete-cel. 5.1.1. Target Expression Screening Participants are eligible to be screened for target expression (HLA-A*02:01, A*02:05, or A*02:06 and NY-ESO-1/LAGE-1a) only if all of the following criteria apply:
  • •1. The participant (or legally acceptable representative if applicable) provides written informed consent for the screening process described as Target Expression Screening” in the SoA (Section 1.3).
  • •2. Age =18 years on the day of signing informed consent.
  • •3. Medical Monitor (or designee) approval has been obtained if participants are enrolled or to be enrolled in other experimental interventional clinical studies during the screening and leukapheresis stages of this study (GSK208471).
  • •4. Histologically or cytologically diagnosed unresectable Stage IIIb or Stage IV NSCLC.
  • •a. Arms A and B: Participants with NSCLC lacking actionable genetic aberrations (i.e., wild type) per NCCN guidelines, based on SoC diagnostic test.
  • •b. Arm C: Participants with NSCLC with actionable genetic aberrations (e.g., sensitizing EGFR mutation ALK translocation, etc.) per NCCN guidelines, based on SoC diagnostic test.
  • •5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • •6. Tumor tissue sample with associated pathology report is available to perform tumor antigen expression analysis (NY-ESO-1 or, if tested, LAGE-1a), in alignment with Section 8.9.2. Note: Participants may not need to repeat certain screening/baseline assessments or procedures if performed as part of other GSK studies (see Section 4.1.1.1).
  • •5.1.2. Leukapheresis Eligibility Screening
  • •All screening criteria described in Section 5.1.1 must be reviewed and fulfilled along
  • •with all the following criteria prior to leukapheresis. Leukapheresis process may not be
  • •necessary for participants for which lete-cel cell product is already manufactured.
  • •Additionally, participants may not need to repeat certain screening/baseline assessments
  • •or procedures if performed as part of other GSK studies (see Section 4.1.1.1).
  • •7. The participant has successfully completed the HLA and target expression evaluations.
  • •a. Participant is positive for any of the following alleles: HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by a validated test.
  • •b. Participant’s tumor has been reviewed by the GSK-designated laboratory and confirmed as meeting the pre-defined threshold for expression of NY-ESO-1 and/or, if tested, LAGE-1a
  • •After HLA allele genotyping and tumor antigen expression have been found positive, an
  • •eligible participant must fulfill all the following inclusion criteria:
  • •. Participant (or legally acceptable representative if applicable) provides written

排除标准

  • •5.2.1. Target Expression Screening
  • •Participants are not eligible to be screened for target expression if any of the following criteria apply:
  • •1. Prior treatment:
  • •a. Previous treatment with genetically engineered NY-ESO-1-specific T-cells.
  • •b. Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
  • •c. Prior gene therapy using an integrating vector.
  • •d. Previous allogeneic hematopoietic stem cell transplant.
  • •2. Prior malignancy other than NSCLC, with the following exceptions:
  • •a. Participants with a history of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease
  • •recurrence for 5 years since initiation of that therapy.
  • •3. Participant has undergone prior allogeneic/autologous bone marrow or solid organ
  • •transplantation.
  • •5.2.2. Leukapheresis Eligibility Screening
  • •Participants are not eligible for leukapharesis if any of the Exclusion criteria in Section 5.2.1 apply. Please note that mandatory washout period restrictions must be respected (Table 12) before starting leukapheresis. In addition, participants are not eligible for leukapheresis if any of the following criteria apply:
  • •4.Participant has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, fludarabine, dimethylsulfoxide (DMSO) or other agents used in the study (participants
  • •with vitiligo or resolved childhood asthma/atopy are an exception to this rule)
  • •5. Participant has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of
  • •its excipients.
  • •6. Participant has an active autoimmune disease that has required systemic treatment in
  • •past 2 years (i.e., with use of disease modifying agents, corticosteroids or
  • •immunosuppressive drugs). Replacement therapy (e.g., physiologic corticosteroid
  • •replacement therapy for adrenal or pituitary insufficiency) is not considered a form
  • •of systemic treatment and is allowed.
  • •7. Participant has a history of chronic or recurrent (within the last year prior to
  • •enrollment) severe autoimmune or active immune-mediated disease requiring
  • •steroids or other immunosuppressive treatments.
  • •8. Uncontrolled intercurrent illness including, but not limited to:
  • •a. Ongoing or active infection (including but not limited to systemic fungal
  • •infections)
  • •b. Clinically significant cardiac disease defined by congestive heart failure New
  • •York Heart Association (NYHA) Class >1
  • •c. Uncontrolled clinically significant arrhythmia in last 6 months
  • •d. Acute coronary syndrome (angina or myocardial infarction) in last 6 months
  • •e. Severe aortic stenosis, symptomatic mitral stenosis
  • •f. Inadequate pulmonary function with mechanical parameters <40% predicted
  • •(forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC],
  • •total lung capacity [TLC], pulmonary diffusing capacity for carbon monoxide
  • •9. Participant has active infection with HIV, HBV, HCV, EBV, CMV, syphilis, or
  • •HTLV as defined below:
  • •a. Positive serology for human immunodeficiency virus (HIV).
  • •b. Active hepatitis B infection as demonstrated by test for hepatitis B surface
  • •antigen. Participants who are hepatitis B surface antigen negative but are
  • •hepatitis B core antibody positive must have undetectable hepatitis B DNA and
  • •receive prophylaxis against viral reactivation.
  • •c. Active hepatitis C infection as demonstrated by hepatitis C RNA test.
  • •Participants who are

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