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NCT Number: NCT07256756

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adverse Events

    Time frame: 6 month

    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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 36 months

    Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  2. Disease Control Rate (DCR)

    Time frame: Up to 36 months

    Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  3. Duration of Response (DOR)

    Time frame: Up to 36 months

    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

  4. Progression-Free Survival (PFS)

    Time frame: Up to 36 months

    The time from TIL infusion until disease progression or death from any cause.

  5. Overall Survival(OS)

    Time frame: Up to 36 months

    The time from TIL infusion until death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Cheng

CONTACT

[email protected]

+8621-69110327

Sponsors and collaborators

Lead sponsor

Shanghai Juncell Therapeutics

Industry

Collaborators

  • Shenzhen Hospital of Southern Medical University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Dec 1, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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