NCT06048705

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

Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NYESO1 and LAGE1a, and Co-expressing CD8α (GSK3901961) in Participants With NYESO1 and/or LAGE1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma / Myxoid/Round Cell Liposarcoma; or NYESO1 and/or LAGE1a Positive Previously Treated Metastatic Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Adaptimmune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a substudy of the Master record - (209012) NCT04526509.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	GSK3901961	GSK3901961 was administered.
DRUG	Cyclophosphamide	Cyclophosphamide was administered as lymphodepleting chemotherapy.
DRUG	Fludarabine	Fludarabine was administered as lymphodepleting chemotherapy.

Timeline

• Start date: 2021-03-09
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2023-09-21
• Last updated: 2024-11-13
• Results posted: 2024-05-10

Locations

21 sites across 6 countries: United States, Australia, Canada, Germany, Netherlands, Sweden

Regulatory

• FDA-regulated drug study