Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

GAIA BioMedicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cell Therapy; NSCLC

Treatments: Biological: Biological

Study type: Interventional

Funder types: Industry

Identifiers

NCT05207371

GAIA-102-LC01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

GAIA-102 alone

Experimental group

Description:

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

Treatment:

Biological: Biological

GAIA-102 with Pembrolizumab

Experimental group

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.

Treatment:

Biological: Biological