Cell Therapy, NSCLC
Conditions
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.
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.
Interventions
BIOLOGICALBiological
Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)
Sponsors
GAIA BioMedicine Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who have been confirmed to have NSCLC by histological or cytological examination 2. Patients with ECOG performance status (PS) 0-1 at the time of obtaining consent 3. Patients aged 20 years or older at the time of obtaining consent
Exclusion criteria
1. 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. 2. Patients diagnosed with cancerous meningitis 3. Patients who received allogeneic hematopoietic stem cell transplantation 4. Patients with active autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I part | Cycle 1 (Cycle period is 28 days) | Dose Limiting Toxicity |
| Phase II part | Week 26 | Objective Response Rate (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I part | Week 26 | * Objective Response Rate * Disease Control Rate |
| Phase II part | 2 year | * Progression-free Survival * Overall Survival |
Countries
Japan
Contacts
STUDY_DIRECTORYoshikazu Yonemitsu, MD, PhD
Graduate School of Pharmaceutical Sciences, Kyushu University
Outcome results
None listed