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NOT YET RECRUITING
NCT07766317
PHASE1/PHASE2

Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.

Sponsor: Gritbio Medicine, Inc.

View on ClinicalTrials.gov

Summary

This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.

Official title: A Phase I/II Open-Label Clinical Study of Autologous Tumor Infiltrating Lymphocyte Infusion (GT201) in the Treatment of Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2026-11

Completion Date

2032-06

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

GT201

A tumor sample from individual participant is collected through a surgical resection for ex vivo manufacturing of GT201 TIL cell product.

BIOLOGICAL

IL-2 and PD-1

Participants tandemly receives a lymphodepleting regimen, GT201 TIL product, and IL-2. Some participants may also receive a PD-1 inhibitor following GT201 infusion