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

Conditions: Neoplasms

Summary: 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.

this study is a substudy of the master record - (209012) nct04526509.

Eligibility criteria:
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

Keywords: adoptive t cell therapy advanced synovial sarcoma advanced myxoid/round cell liposarcoma advanced tumors gsk3901961 t cell receptor leukapheresis non-small cell lung cancer