Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.

NCT07766317 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: GT-CD-CHN-201-01
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Tumor Infiltrating Lymphocyte; TIL

Outcome Measures

Primary Outcomes (4)

• To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors

  Incidence and severity of AEs will be graded per NCICTCAE v5.0 (Phase 1)

  Upto 2 years

• To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors

  Incidence and severity of CRS and ICANS AE's will be graded per the ASTCT criteria (Phase 1)

  Upto 2 years

• To assess the tolerance of GT201 and decide on the recommended Phase 2 dose.

  The safest combination will be used to determine recommended dose for Phase 2 (RP2D) (Phase 1)

  Upto 2 years

• To assess the Objective Response Rate (ORR) of GT201 infusion in accordance with RECIST v1.1

  To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) (Phase 2)

  Upto 2 years

Secondary Outcomes (5)

• To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: Objective response rate (ORR)

  Upto 2 years

• To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: duration of response (DOR)

  Upto 2 years

• To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: disease control rate (DCR)

  Upto 2 years

• To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: progression free survival (PFS)

  Upto 2 years

• To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: overall survival (OS)

  Upto 2 years

Other Outcomes (1)

• Evaluate the persistence of GT201 cells in the treatment of recurrent or metastatic solid tumors

  Upto 2 years

Study Arms (1)

Participants with advanced solid tumors

EXPERIMENTAL

Biological: GT201; Biological: IL-2 and PD-1

Interventions

GT201 BIOLOGICAL

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

Participants with advanced solid tumors

IL-2 and PD-1 BIOLOGICAL

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

Participants with advanced solid tumors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~70 years old;
• Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;
• At least one lesion that is resectable for the preparation of autologous TIL cells;
• At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Expected survival ≥ 12 weeks;
• Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion.

You may not qualify if:

• Subjects will be excluded from the study for one or more of the following conditions:
• Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);
• Bleeding events within 3 months prior to screening
• Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening
• Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;
• Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class grade \> grade 2;
• Participants with ≥ 3 untreated central nervous system (CNS) metastases;
• Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (\> 10 mg/day of prednisone or equivalent);
• Malignant tumors other than the target indication within 5 years;
• The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use;
• Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV.
• Previous allogeneic bone marrow transplantation or solid organ transplantation;

Sponsors & Collaborators

• Gritbio Medicine, Inc.: lead

MeSH Terms

Interventions

Interleukin-2

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Central Study Contacts

Gritbio Study Team

CONTACT

440-414-3338; GT201.inquiries@grit-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2032
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share