Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
Who is this study for? Patients with advanced and relapsed NSCLC
What treatments are being studied? GAIA-102
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Kitakyushu Municipal Medical Center
RECRUITING
Kitakyushu
Kurume University Hospital
RECRUITING
Kurume
Contact Information
Primary
Masayoshi Tashiro, master
mtashiro@gaia-biomed.com
+81-92-642-4708
Backup
Keiji Toya, master
ktoya@gaia-biomed.com
+81-92-642-4708
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 38
Treatments
Experimental: GAIA-102 alone
GAIA-102: 1 vial (2 x 10\^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.
Experimental: GAIA-102 with Pembrolizumab
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.
Related Therapeutic Areas
Sponsors
Leads: GAIA BioMedicine Inc.