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Recruiting

NCT Number: NCT06488950

A Study of TIL in Advanced Solid Tumors (DFGD)

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Third Affiliated Hospital of Naval Medical University

Shanghai, China

Location status: Recruiting

Location contact

Qian Zhang

PRINCIPAL_INVESTIGATOR

Wenlong Yu

PRINCIPAL_INVESTIGATOR

Xiaoyun Tai

CONTACT

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 TILs production and successfully produced;
  • Age: 18 years to 75years;
  • Histologically diagnosed as solid tumors;
  • Expected life-span more than 3 months;
  • ECOG score 0-1;
  • Test subjects have failed standard treatment regimens, and be willing to receive 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(gene-edited TIL) or autologous TILs

Biological

the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample

Primary outcomes

  1. Adverse Events

    Time frame: 6 months

    To characterize the safety profile of TILs in patients with advanced 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

    Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1

  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 length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

Study contacts

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

GC Clinical

CONTACT

[email protected]

086-18001759113

Sponsors and collaborators

Lead sponsor

Shanghai Juncell Therapeutics

Industry

Collaborators

  • Eastern Hepatobiliary Surgery Hospital

Registry information

Official study title

A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Dec 16, 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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