GAIA BioMedicine Inc. has started Phase Ⅰ/Ⅱ clinical trial of its proprietary GAIA-102, NK-cell-like cells, for Non-Small Cell Lung Cancer
GAIA BioMedicine Inc. (“GAIA”), a pioneer in developing innovative immunotherapies, announced that the firm has started Phase Ⅰ/Ⅱ clinical trial of its proprietary GAIA-102, NK-cell-like cells, for Non-Small Cell Lung Cancer (NSCLC). GAIA conducts this trial as a singular-group, multi-site, non-randomized, open, and uncontrolled study to evaluate GAIA-102’s safety and efficiency for NSCLC.
Phase Ⅰ has a typical “3 + 3” design. This phase assesses the safety and tolerability of GAIA-102 as monotherapy (labeled as cohort A) and the combination therapy of GAIA-102 with Pembrolizumab (labeled as cohort B), determining the recommended dosing frequency.
Subject to an Independent Data Monitoring Committee’s (IDMC) review of the safety data of all enrolled subjects in each cohort at each dose level, the dose escalation to the next level will be determined.
In Phase Ⅱ of the trial, GAIA will enroll an additional 20 subjects to evaluate the safety and clinical efficacy of the monotherapy of GAIA-102 and the combination therapy of GAIA-102 and Pembrolizumab for NSCLC. The primary endpoint of Phase Ⅱ is the overall response rate (ORR).
By the end of October, 4 subjects had been treated: three in A1, the lowest-dose monotherapy cohort, and one in B1, the lowest-dose combination therapy. No dose-limiting toxicities (DLT) have been confirmed.
ClinicalTrials.gov Identifier: NCT05207371