Cell TherapyPhase 1/2NCT05207371
Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
A Phase 1/2 study testing Biological in people with Cell Therapy and NSCLC, run by GAIA BioMedicine Inc. at 3 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cell Therapy, NSCLC
- What is being tested?
- Biological
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesJapan
- Study dates
- 1 Dec 2021to 6 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Kitakyushu Municipal Medical Center
Kitakyushu, Fukuoka, 802-8561
Kurume University Hospital
Kurume, Fukuoka, 830-0011
About this study
Official title: Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
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.
Read the 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
- Being tested
- Biological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiologicalBiological
Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)
| Study group | Role | What they receive |
|---|---|---|
| GAIA-102 alone | Experimental | GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks. Receives: Biological: Biological |
| GAIA-102 with Pembrolizumab | 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. Receives: Biological: Biological |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I part
Dose Limiting Toxicity
Measured: Cycle 1 (Cycle period is 28 days)
Phase II part
Objective Response Rate (%)
Measured: Week 26
Secondary outcomes (3)
Phase I part
- Objective Response Rate
- Disease Control Rate
Measured: Week 26
Phase I part
- Progression-free Survival
- Overall Survival
Measured: 2 year
Phase II part
- Progression-free Survival
- Overall Survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Sep 2024
- Study completion6 Mar 2026
Why it stopped: Decision based on the development company's development policy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GAIA BioMedicine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshikazu Yonemitsu, MD, PhD, Study director, Graduate School of Pharmaceutical Sciences, Kyushu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207371
- Sponsor's protocol ID
- GAIA-102-LC01
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
- ClinicalTrials.gov ID
- NCT05207371
- Acronym / sponsor ID
- GAIA-102-LC01
- Conditions
- Cell Therapy, NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision based on the development company's development policy
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GAIA BioMedicine Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAIA-102 alone | Experimental | Biological: BiologicalGAIA-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 | Experimental | Biological: BiologicalGAIA-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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiologicalIntravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎) | Biological | GAIA-102 alone, GAIA-102 with Pembrolizumab |
Primary outcome
Phase I part
Time frame: Cycle 1 (Cycle period is 28 days)
Dose Limiting Toxicity
Phase II part
Time frame: Week 26
Objective Response Rate (%)
3 secondary outcomes
Phase I part
Time frame: Week 26
Phase I part
Time frame: 2 year
Phase II part
Time frame: 2 year
Results and safety
The study was stopped early (reason given: Decision based on the development company's development policy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Related trials for Cell Therapy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshikazu Yonemitsu, MD, PhD study director
Graduate School of Pharmaceutical Sciences, Kyushu University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biological in people with Cell Therapy and NSCLC, run by GAIA BioMedicine Inc. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decision based on the development company's development policy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I part (time frame: Cycle 1 (Cycle period is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.