Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Sponsor

GAIA BioMedicine Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05207371

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

12.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cell Therapy NSCLC	Biological: Biological	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Biological: Biological Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)
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.	Biological: Biological Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)

Arm

Intervention/Treatment

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.

Biological: Biological

Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)

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.

Biological: Biological

Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)

Outcome Measures

Primary Outcome Measures

Phase I part [Cycle 1 (Cycle period is 28 days)]
Dose Limiting Toxicity
Phase II part [Week 26]
Objective Response Rate (%)

Secondary Outcome Measures

Phase I part [Week 26]
Objective Response Rate Disease Control Rate
Phase I part [2 year]
Progression-free Survival Overall Survival
Phase II part [2 year]
Progression-free Survival Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyushu University Hospital	Fukuoka-shi	Fukuoka	Japan	812-8582
2	Kitakyushu Municipal Medical Center	Kitakyushu	Fukuoka	Japan	802-8561
3	Kurume University Hospital	Kurume	Fukuoka	Japan	830-0011

Sponsors and Collaborators

GAIA BioMedicine Inc.

Investigators

Study Director: Yoshikazu Yonemitsu, MD, PhD, Graduate School of Pharmaceutical Sciences, Kyushu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GAIA BioMedicine Inc.

ClinicalTrials.gov Identifier:

NCT05207371

Other Study ID Numbers:

GAIA-102-LC01

First Posted:

Jan 26, 2022

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Recurrence

Study Results

No Results Posted as of Jan 26, 2022