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Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.

NCT07766317 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumors Cancer

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

Sponsors & Collaborators

  • Gritbio Medicine, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2030-06-30
Completion
2032-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766317 on ClinicalTrials.gov