Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

• Status: Active, not recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cyclophosphamide; Fludarabine

Criteria

Inclusion Criteria:

• Participant must be greater than or equal to 10 years of age 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 by a designated central laboratory

• Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory.

• Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)

• Performance status: dependent on age - Lansky > 60, Karnofsky > 60, Eastern

• Cooperative Oncology Group 0-1.

• Participant must have adequate organ function and blood cell counts, within 7 days prior to leukapheresis.

• At time of treatment, participant has measurable disease according to RECIST v1.1.

• Consultation for prior history per protocol specifications.

Exclusion Criteria:

• Central nervous system metastases.

• 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 (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments.

• Previous treatment with genetically engineered NY-ESO-1-specific T cells.

• Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.

• Prior gene therapy using an integrating vector.

• Previous allogeneic hematopoietic stem cell transplant.

• Washout periods for prior radiotherapy and systemic chemotherapy must be followed.

• Participant had major surgery in less than or equal to 28 days of first dose of study intervention.

• Prior radiation exceeds protocol specified limits.