NCT05207371

Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: GAIA BioMedicine Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Phase I Part : Confirm the safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer, and decide recommended dose for Phase II. Phase II Part : Explore the efficacy and safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer at the recommended dose of GAIA-102 decided in the Phase I part.

Detailed description

Phase I Part : The GAIA-102 cohort (Level A1\~A3) and the GAIA-102 + Pembrolizumab cohort (Level B1\~B3) will be implemented in a 3 + 3 design. First, start from Level A1 and set the DLT evaluation period until Day 28 of Cycle 1, and confirm the safety up to Cycle 1\_Day 28 of Level A1. After that, Level A2 and Level B1 will be started in parallel. After that, unless MTD is recognized, the safety at each level will be confirmed in sequence, and the recommended doses of Phase II part will be determined. Phase II Part : At the recommended number of doses confirmed in Phase I Part, 20 patients will be administered up to 3 cycles, and the safety and efficacy of GAIA-102 alone or with pembrolizumab will be evaluated by ORR.

Conditions

• Cell Therapy
• NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	Biological	Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-10-01
• Completion: 2025-12-01
• First posted: 2022-01-26
• Last updated: 2022-01-26

Locations

3 sites across 1 country: Japan