Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
1 other identifier
interventional
38
1 country
3
Brief 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 cancer at the recommended dose of GAIA-102 decided in the Phase I part.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2021
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 26, 2022
January 1, 2022
10 months
November 19, 2021
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Phase I part
Dose Limiting Toxicity
Cycle 1 (Cycle period is 28 days)
Phase II part
Objective Response Rate (%)
Week 26
Secondary Outcomes (3)
Phase I part
Week 26
Phase I part
2 year
Phase II part
2 year
Study Arms (2)
GAIA-102 alone
EXPERIMENTALGAIA-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
EXPERIMENTALGAIA-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.
Interventions
Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kitakyushu Municipal Medical Center
Kitakyushu, Fukuoka, 802-8561, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yoshikazu Yonemitsu, MD, PhD
Graduate School of Pharmaceutical Sciences, Kyushu University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2021
First Posted
January 26, 2022
Study Start
December 1, 2021
Primary Completion
October 1, 2022
Study Completion
December 1, 2025
Last Updated
January 26, 2022
Record last verified: 2022-01