Status:
UNKNOWN
Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
Lead Sponsor:
GAIA BioMedicine Inc.
Conditions:
Cell Therapy
NSCLC
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
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 : Explo...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05207371
Start Date
December 1 2021
End Date
December 1 2025
Last Update
January 26 2022
Active Locations (3)
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1
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
2
Kitakyushu Municipal Medical Center
Kitakyushu, Fukuoka, Japan, 802-8561
3
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011