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GAIA-102 in Advanced and Relapse NSCLC
NCT05207371Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2021
- Primary completion
- Sep 2024
- Countries
- 1
- Sponsor
- GAIA BioMedicine
- Modality
- Lymphokine-Activated Killer Cells, CAR-NK Cells
- Drugs
- GAIA-102
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label trial of GAIA-102 in non-small cell lung cancer (NSCLC) (2 arms), sponsored by GAIA BioMedicine. Primary endpoints: Safety and Dose-Limiting Toxicities (Phase I) and Objective Response Rate (Phase II) at Week 26. Started Dec 2021; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
GAIA-102 alone
GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.
GAIA-102 with Pembrolizumab
GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks. Pembrolizumab: 200 mg administered on Day 1.
03
Who it enrols
Patients aged 20 years or older with histologically or cytologically confirmed NSCLC and ECOG PS 0-1. Excludes patients with symptomatic CNS metastasis, cancerous meningitis, prior allogeneic hematopoietic stem cell transplantation, or active autoimmune disease.
04
Endpoints
Primary
Safety and Dose-Limiting Toxicities (Phase I)
Objective Response Rate (Phase II)
Secondary
Safety and Efficacy (Phase I)
Safety and Efficacy (Phase II)
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