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

A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors, Adult
• Intervention / Treatment: Biological: GC203 TIL

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Cheng; Phone Number: +8621-69110327; Email: ying.cheng@juncell.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• with other malignant tumors,except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GC203 TIL; participants with advanced solid tumors using cryopreserved GC203 TIL	Biological: GC203 TIL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1	Up to 36 months
Objective Response Rate (ORR)	Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	Up to 36 months
Disease Control Rate (DCR）	Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	Up to 36 months
Progression-Free Survival (PFS)	The time from TIL infusion until disease progression or death from any cause.	Up to 36 months
Overall Survival(OS)	The time from TIL infusion until death from any cause.	Up to 36 months

Collaborators and Investigators

• Sponsor: Shanghai Juncell Therapeutics
• Collaborators: Shenzhen Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GC203-2025-NF-ST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No