Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Cell Therapy
• Intervention / Treatment: Biological: Biological

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 Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Masayoshi Tashiro, master; Phone Number: +81-92-642-4708; Email: mtashiro@gaia-biomed.com
• Study Contact Backup: Name: Keiji Toya, master; Phone Number: +81-92-642-4708; Email: ktoya@gaia-biomed.com

Study Locations

• Japan
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Recruiting
      • Kyushu University Hospital
      • Contact: Masayoshi Tashiro; Phone Number: +81-92-641-1151; Email: mtashiro@gaia-biomed.com
      • Principal Investigator: Isamu Okamoto
    • Kitakyushu, Fukuoka, Japan, 802-8561
      • Recruiting
      • Kitakyushu Municipal Medical Center
      • Contact: Masayoshi Tashiro; Phone Number: +81-92-641-1151; Email: mtashiro@gaia-biomed.com
      • Principal Investigator: Kohei Otsubo
    • Kurume, Fukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital
      • Contact: Masayoshi Tashiro; Phone Number: +81-92-641-1151; Email: mtashiro@gaia-biomed.com
      • Principal Investigator: Koichi Azuma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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®︎)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I part	Dose Limiting Toxicity	Cycle 1 (Cycle period is 28 days)
Phase II part	Objective Response Rate (%)	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I part	Objective Response Rate; Disease Control Rate	Week 26
Phase I part	Progression-free Survival; Overall Survival	2 year
Phase II part	Progression-free Survival; Overall Survival	2 year

Collaborators and Investigators

• Sponsor: GAIA BioMedicine Inc.
• Investigators: Study Director: Yoshikazu Yonemitsu, MD, PhD, Graduate School of Pharmaceutical Sciences, Kyushu University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
• Other Study ID Numbers: GAIA-102-LC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No