NL-OMON52531已完成2 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 (study 208471) - 208471
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
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
- •Male or female, age 18 years and above.
- •Histologically or cytologically diagnosed unresectable Stage IIIb or Stage IV
- •NSCLC. Measurable disease is not an indispensable requirement for
- •enrollment/leukapheresis.
- •ECOG performance status 0-1.
- •Life expectancy of at least 3 months.
- •Left ventricular ejection fraction >=50% or as per institution*s guidelines.
- •Adequate venous access for leukapheresis.
- •Participant is positive for any of the following alleles: HLA-A*02:01, HLA
- •A*02:05, HLA-A*02:06.
- •Tumor tissue (archival biopsy) obtained at any time from the initial
- •diagnosis to time of study entry is mandatory for tumor antigen expression
- •analysis (NY-ESO-1 and/or LAGE1a). In case an archival biopsy is not available
- •a fresh biopsy may be considered in consultation with the sponsor.
- •LEUKAPHERESIS:
- •Successfully completed screening: HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06
- •positive and meeting the threshold for expression of NY-ESO-1 and/or LAGE1a.
- •Suitable for leukapheresis, including the laboratory parameters mentioned in
- •chapter 5.1.2, item 12 of the protocol.
- •Time point of leukapheresis the treatment scheme: see chapter 5.1.2, item 13
- •of the protocol for details.
- •CHEMOTHERAPY/TREATMENT:
- •Must have received or are receiving at least 1 line of prior systemic
- •therapy. See chapter 5.1.3, item 15 of the protocol for details.
- •Following treatment with a PD-1/PD-L1 checkpoint blockade therapy
- •administered either as monotherapy or in combination with other checkpoint
- •inhibitors or other therapies, progression is defined by meeting all of the
- •criteria defined in chapter 5.1.3, item 15b of the protocol.
- •Histologically or cytologically diagnosed unresectable Stage IIIb or Stage IV
- •NSCLC with measurable disease per RECIST v1.1.
- •Prior radiotherapy: For prior chest radiotherapy see D5a (exclusion criteria)
- •for details. Allowed in case of prior palliative or stereotactic radiosurgery
- •to solitary lesions outside of the chest.
- •Acceptance of CNS metastases: see chapter 5.1.3, item 19 of the protocol for
- •Acceptance of initiation of the chemotherapy: see chapter 5.1.3, item 20 of
- •the protocol for details.
- •Acceptance of standard of care line of therapy between leukapheresis and
- •treatment: see chapter 5.1.3, item 21 of the protocol for details.
- •Contraception guidelines for males and females should be followed, see
- •chapter 5.1.3, item 23 and 5.3.3 of the protocol for details.
- •Pembrolizumab treatment (rescue) for Arm A: see chapter 5.1.4 of the protocol
- •for details.
排除标准
- •Has received >=3 lines of prior systemic therapy. See protocol section 5.2.1
- •Prior treatment: See protocol section 5.2.1:
- •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.
- •Prior malignancy other than NSCLC. Exceptions: see chapter 5.2.1, item 2.
- •Active autoimmune disease or history. See chapter 5.2.2 item 6,7.
- •Uncontrolled intercurrent infection, cardiac, pulmonary, demyelinating
- •disease, or unstable liver or biliary disease. See chapter 5.2.2, item 8.
- •Active infection with HIV, hepatitis B, hepatitis C, EBV, CMV, syphilis,
- •HTLV. See chapter 5.2.2, item 9 of the protocol for details.
- •QTc >450 msec or QTc >480 msec for patients with BBB. See chapter 5.2.2, item
- •13 of the protocol for details.
- •LEUKAPHERESIS:
- •Investigational treatment within 30 days or 5 half-lives (whichever is
- •shorter). See chapter 5.2.2, item 15 of the protocol for details.
- •Radiotherapy that involves the lung or >25% bone marrow exposure, or mean
- •heart dose >20Gy within 3 months. See chapter 5.2.2, item 19 of the protocol
- •for details.
- •CHEMOTHERAPY/TREATMENT:
- •Corticosteroids other than inhaled or topical or any other immunosuppressive
- •therapy within 2 weeks.
- •Live vaccine within 30 days prior to the first dose of study drug. See
- •chapter 5.2.2, table 12 of the protocol for details.
- •Pembrolizumab treatment (rescue) for Arm A: see chapter 5.2.4 of the protocol
- •for details.
研究者
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