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Recruiting NCT07256756

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

Phase I Interventional Solid Tumors, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GC203 TIL.
Who it may be relevant to
Registry conditions: Solid Tumors, Adult. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Adverse Events [Time frame: 6 month]
Secondary outcome measures (5)
  • Objective Response Rate (ORR) [Time frame: Up to 36 months]
  • Disease Control Rate (DCR） [Time frame: Up to 36 months]
  • Duration of Response (DOR) [Time frame: Up to 36 months]
  • Progression-Free Survival (PFS) [Time frame: Up to 36 months]
  • Overall Survival(OS) [Time frame: Up to 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shenzhen Hospital of Southern Medical University — Shenzhen

Identifiers

NCT: NCT07256756 · GC203-2025-NF-ST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗