Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer
The primary purpose of this sub study is to assess the safety, tolerability and determine recommended Phase 2 dose (RP2D) of GSK3901961 in HLA A\*02:01, HLA-A\*02:05 and/or HLA A\*02:06 positive participants with New York esophageal squamous cell carcinoma (NY ESO 1) and/or Cancer testis antigen 2 (LAGE 1a) positive previously treated metastatic Non-Small Cell Lung Cancer (NSCLC) and previously treated, advanced (metastatic or unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma SS/MRCLS.
Checked against the public recordLast updated Nov 13, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Adaptimmune
- Interventions being studied
- Drug: GSK3901961; Drug: Cyclophosphamide; Drug: Fludarabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Participant must be \>=18 years of age and weighs ≥40 kg on the day of signing informed consent * Participant must be positive for HLA-A\*02:01, HLA-A\*02:05, and/or HLA-A\*02:06 alleles * Participant's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a expression by a GSK designated laboratory * Performance status: Eastern Cooperative Oncology Group of 0-1 * Participant must have adequate organ function and blood cell counts 7 days prior to leukapheresis * Participant must have measurable disease according to RECIST v1.1. * Participant has advanced (metastatic or unresectable) SS or MRCLS confirmed by local histopathology with evidence of disease-specific translocation * Participant has completed at least one standard of care (SOC) treatment including anthracycline containing regimen unless intolerant to or ineligible to receive the therapy. * Participants who are not candidates to receive anthracycline should have received ifosfamide unless also intolerant to or ineligible to receive ifosfamide. Participants who received neoadjuvant/adjuvant anthracycline or ifosfamide based therapy and progressed will be eligible * Participant has histologically or cytologically confirmed Stage IV NSCLC * Participant has been previously treated with SOC for Stage IV NSCLC Exclusion Criteria: * Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in NSCLC as specified in the protocol * Any other prior malignancy that is not in complete remission * Clinically significant systemic illness * Prior or active demyelinating disease * History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments * Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1 vaccine or NY-ESO-1 targeting antibody * Prior gene therapy using an integrating vector * Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant * Washout periods for prior radiotherapy and systemic chemotherapy must be followed * Major surgery within 4 weeks prior to lymphodepletion * Pregnant or breastfeeding females
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- GSK Investigational SiteNew Haven, Connecticut
- GSK Investigational SiteJacksonville, Florida
- GSK Investigational SiteTampa, Florida
- GSK Investigational SiteAtlanta, Georgia
- GSK Investigational SiteWestwood, Kansas
- GSK Investigational SiteLexington, Kentucky
- GSK Investigational SiteBaltimore, Maryland
- GSK Investigational SiteSt Louis, Missouri
- GSK Investigational SiteNew York, New York
- GSK Investigational SiteNew York, New York
- GSK Investigational SitePhiladelphia, Pennsylvania
- GSK Investigational SiteHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2024. Always confirm current availability with the study team.