Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Study Overview
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Brief Summary
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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
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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 Title
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Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Conditions
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NSCLC, Cell Therapy

Intervention / Treatment
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* Biological: Biological


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAIA-102 alone<br>GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks. | Biological: Biological<br>* Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)<br>|
| Experimental: GAIA-102 with Pembrolizumab<br>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. | Biological: Biological<br>* Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I part | Dose Limiting Toxicity | Cycle 1 (Cycle period is 28 days) | 
| Phase II part | Objective Response Rate (%) | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I part | Objective Response Rate Disease Control Rate | Week 26 | 
| Phase I part | Progression-free Survival Overall Survival | 2 year | 
| Phase II part | Progression-free Survival Overall Survival | 2 year |