A Study of GC203 TIL in Advanced Solid Tumors (NF)

NCT07256756 | Not Yet Recruiting Phase 1

• 1 other identifier: GC203-2025-NF-ST
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.

Conditions

Solid Tumors, Adult

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  To characterize the safety profile of GC203 TIL in patients with Solid Tumors who were failed to standard treatment as assessed by incidence of adverse events.

  6 month

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to 36 months

• Disease Control Rate (DCR）

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Progression-Free Survival (PFS)

  Up to 36 months

• Overall Survival(OS)

  Up to 36 months

Study Arms (1)

GC203 TIL

EXPERIMENTAL

participants with advanced solid tumors using cryopreserved GC203 TIL

Biological: GC203 TIL

Interventions

GC203 TIL BIOLOGICAL

A tumor sample is resected from each participant and cultured ex vivo to expand the population of engineered tumor infiltrating lymphocytes injection (GC203 TIL). After lymphodepletion, patients are infused GC203 TIL.

GC203 TIL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have one the tumor resection for gene-edited GC203 TIL production and successfully produced；
• Age: 18 years to 75years;
• Histologically diagnosed as solid tumor;
• Expected life-span more than 3 months;
• ECOG score 0-1;
• Test subjects have failed standard treatment regimens, and be willing to receive engineered GC203 TIL therapy;
• At least 1 evaluable tumor lesion;

You may not qualify if:

• Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
• Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%;
• Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
• Significant cardiovascular anomalies

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead
• Shenzhen Hospital of Southern Medical University: collaborator

Central Study Contacts

Ying Cheng

CONTACT

+8621-69110327; ying.cheng@juncell.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: November 20, 2025
• First Posted: December 1, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-11