Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC | NCT05207371

Studies
Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

NCT05207371

Sponsor

GAIA BioMedicine Inc.

Status

Unknown status

Last Update Posted

Jan 26, 2022Actual

Enrollment

38Estimated

Phase

Phase 1Phase 2

Conditions

Cell Therapy
NSCLC

Interventions

Biological

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Nov 19, 2021

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2022

Last Update Posted Date

Jan 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GAIA-102 alone	Experimental	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
GAIA-102 with Pembrolizumab	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological	Biological	Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)	GAIA-102 alone GAIA-102 with Pembrolizumab

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Phase I part	Objective Response Rate Disease Control Rate	Week 26
Phase I part	Progression-free Survival Overall Survival

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Masayoshi Tashiro, master	Contact	+81-92-642-4708		mtashiro@gaia-biomed.com
Keiji Toya, master	Contact	+81-92-642-4708		ktoya@gaia-biomed.com

Overall Officials

Name	Affiliation	Role
Yoshikazu Yonemitsu, MD, PhD	Graduate School of Pharmaceutical Sciences, Kyushu University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyushu University Hospital	Recruiting	Fukuoka	Fukuoka	812-8582	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D001688	Biological Products

Ancestor Terms

ID	Term
D045424	Complex Mixtures

Browse Leaves

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Browse Branches

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