Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors
Phase 1
Terminated
- Conditions
- Neoplasms
- Interventions
- Registration Number
- NCT04526509
- Lead Sponsor
- Adaptimmune
- Brief Summary
This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors.
- Detailed Description
This study is a master protocol. It has two sub studies registered as 209012 Sub Study 1 (NCT06048705) and 209012 Sub Study 2 (NCT05943990).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC GSK3901961 Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy. Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS GSK3901961 Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy. Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC Fludarabine Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy. Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS GSK4427296 Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy. Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS GSK3845097 Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy. Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC Cyclophosphamide Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy. Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS Cyclophosphamide Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy. Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS Fludarabine Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy. Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS Cyclophosphamide Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy. Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS Fludarabine Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy. Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS Cyclophosphamide Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy. Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS Fludarabine Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
- Primary Outcome Measures
Name Time Method Number of Participants Enrolled Across Sub Studies Day -7 Number of Participants Randomized across sub studies are presented.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇸🇪Stockholm, Sweden