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Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Primary Purpose

Cell Therapy, NSCLC

Status

Recruiting

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Biological

About this trial

This is an interventional treatment trial for Cell Therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kyushu University HospitalRecruiting
Kitakyushu Municipal Medical CenterRecruiting
Kurume University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GAIA-102 alone

GAIA-102 with Pembrolizumab

Arm Description

GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.

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.

Outcomes

Primary Outcome Measures

Phase I part

Dose Limiting Toxicity

Phase II part

Objective Response Rate (%)

Secondary Outcome Measures

Phase I part

Objective Response Rate Disease Control Rate

Phase I part

Progression-free Survival Overall Survival

Phase II part

Progression-free Survival Overall Survival

Full Information

NCT ID

NCT05207371

First Posted

November 19, 2021

Last Updated

January 13, 2022

Sponsor

GAIA BioMedicine Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05207371

Brief Title

Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

October 1, 2022 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GAIA BioMedicine Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cell Therapy, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GAIA-102 alone

Arm Type

Experimental

Arm Description

GAIA-102: 1 vial (2 x 10^8 cells) / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.

Arm Title

GAIA-102 with Pembrolizumab

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Biological

Intervention Description

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

Primary Outcome Measure Information:

Title

Phase I part

Description

Dose Limiting Toxicity

Time Frame

Cycle 1 (Cycle period is 28 days)

Title

Phase II part

Description

Objective Response Rate (%)

Time Frame

Week 26

Secondary Outcome Measure Information:

Title

Phase I part

Description

Objective Response Rate Disease Control Rate

Time Frame

Week 26

Title

Phase I part

Description

Progression-free Survival Overall Survival

Time Frame

2 year

Title

Phase II part

Description

Progression-free Survival Overall Survival

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Masayoshi Tashiro, master

Phone

+81-92-642-4708

mtashiro@gaia-biomed.com

First Name & Middle Initial & Last Name or Official Title & Degree

Keiji Toya, master

Phone

+81-92-642-4708

ktoya@gaia-biomed.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoshikazu Yonemitsu, MD, PhD

Organizational Affiliation

Graduate School of Pharmaceutical Sciences, Kyushu University

Official's Role

Study Director

Facility Information:

Facility Name

Kyushu University Hospital

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Masayoshi Tashiro

Phone

+81-92-641-1151

mtashiro@gaia-biomed.com

First Name & Middle Initial & Last Name & Degree

Isamu Okamoto

Facility Name

Kitakyushu Municipal Medical Center

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

802-8561

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Masayoshi Tashiro

Phone

+81-92-641-1151

mtashiro@gaia-biomed.com

First Name & Middle Initial & Last Name & Degree

Kohei Otsubo

Facility Name

Kurume University Hospital

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Masayoshi Tashiro

Phone

+81-92-641-1151

mtashiro@gaia-biomed.com

First Name & Middle Initial & Last Name & Degree

Koichi Azuma

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

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