Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207371
• Other study ID #: GAIA-102-LC01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2022
• Source: GAIA BioMedicine Inc.
• Contact: Masayoshi Tashiro, master
• Phone: +81-92-642-4708
• Email: mtashiro[@]gaia-biomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 1, 2025
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cell Therapy
• NSCLC
• Recurrence

Intervention

Biological:
• Biological
Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®?)

Locations

Country	Name	City	State
Japan	Kyushu University Hospital	Fukuoka-shi	Fukuoka
Japan	Kitakyushu Municipal Medical Center	Kitakyushu	Fukuoka
Japan	Kurume University Hospital	Kurume	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
GAIA BioMedicine Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I part	Dose Limiting Toxicity	Cycle 1 (Cycle period is 28 days)
Primary	Phase II part	Objective Response Rate (%)	Week 26
Secondary	Phase I part	Objective Response Rate; Disease Control Rate	Week 26
Secondary	Phase I part	Progression-free Survival; Overall Survival	2 year
Secondary	Phase II part	Progression-free Survival; Overall Survival	2 year