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Closed (no longer recruiting)Last updated: 5 February 2024

This Phase I trial is trying to understand the safety and effectiveness of targeted immunotherapy people with previously untreated synovial sarcoma and/or non-small cell lung cancerMaster Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors

Clinical summary

Summary

This is a master protocol evaluating first time in human T-cell therapies. It will initially consist of two independent substudies, investigating GSK3901961 and GSK3845097 in HLA*A02+ participants with NYESO1+ previously treated advanced (metastatic or unresectable) synovial sarcoma (SS) and/or previously treated metastatic non-small cell lung cancer (NSCLC). In Substudy 1: GSK3901961 in previously treated advanced SS, eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy. In Substudy 1: GSK3901961 in previously treated metastatic NSCLC, eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as a single IV infusion after completing lymphodepleting chemotherapy. In Substudy 2: Substudy 2: GSK3845097 in previously treated advanced SS, eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as a single IV infusion after completing lymphodepleting chemotherapy.

Conditions

This trial is treating patients with HLA*A02+ Synovial Sarcoma and Non-Small Cell Lung Cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

GlaxoSmithKline

Scientific Title

Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors

Eligibility

Inclusion

  • 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.

Additional criteria for participants with SS/ MRCLS:

  • 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

Additional criteria for participants with non-small cell lung cancer (NSCLC):

  • Participant has Stage IV NSCLC as confirmed by histology or cytology
  • Prior therapies for participants lacking actionable genetic aberrations (i.e., wild type), per National Comprehensive Cancer Network (NCCN) guidelines: participant has been previously treated with or is intolerant to programmed death receptor-1 (PD)-1/Programmed death ligand 1 (PD-L1) checkpoint blockade therapy and has been previously treated with or is intolerant to a platinum-based chemotherapy. Adjuvant therapy will count as a regimen if completed within 6 months before relapse. Or for participants that harbors an actionable genetic aberration (e.g. BRAF, anaplastic lymphoma kinase [ALK]/ c-ros oncogene 1 [ROS1] etc.), per NCCN guidelines: participants has been previously treated with or is intolerant to SOC therapy, including targeted therapy, as recommended by NCCN or equivalent country-level guidelines (European Society for Medical Oncology [ESMO], National Institute for Health & Care Excellence [NICE]) . Or Investigator has decided that additional lines of SOC therapy after the first line are not in the participant's best interest.

Exclusion

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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