Suspended

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

What is being tested

Biological

Who is being recruted

Over 20 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: December 2021

See protocol details

Summary

Principal SponsorGAIA BioMedicine Inc.

Study ContactMasayoshi Tashiro, masterMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2021

Actual date on which the first participant was enrolled.

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.

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

NCT05207371

Principal SponsorGAIA BioMedicine Inc.

Study ContactMasayoshi Tashiro, masterMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

Patients who have been confirmed to have NSCLC by histological or cytological examination

Patients with ECOG performance status (PS) 0-1 at the time of obtaining consent

Patients aged 20 years or older at the time of obtaining consent

4 exclusion criteria prevent from participating

Patients with symptomatological cranial nerve system metastasis. If treatment for cranial nerve system metastasis has already been performed and the neurologically recovered state has been maintained for 2 weeks or more before registration, registration is possible.

Patients diagnosed with cancerous meningitis

Patients who received allogeneic hematopoietic stem cell transplantation

Patients with active autoimmune disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

GAIA-102: 1 vial (2 x 10\^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.

Group II

Experimental

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 Administer on Day 1.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Kyushu University Hospital

Fukuoka, JapanOpen Kyushu University Hospital in Google Maps

Recruiting

Kitakyushu Municipal Medical Center

Kitakyushu, Japan

Recruiting

Kurume University Hospital

Kurume, Japan

Suspended3 Study Centers