NCT04526509

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Adaptimmune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	GSK3901961	GSK3901961 as an IV infusion.
DRUG	GSK3845097	GSK3845097 as an IV infusion.
DRUG	GSK4427296	GSK4427296 as an IV infusion.
DRUG	Cyclophosphamide	Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
DRUG	Fludarabine	Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.

Timeline

• Start date: 2020-12-21
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2020-08-25
• Last updated: 2024-11-26
• Results posted: 2024-05-10

Locations

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

Regulatory

• FDA-regulated drug study