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A Study of TIL in Advanced Solid Tumors (DFGD) | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

A Study of TIL in Advanced Solid Tumors (DFGD)

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

NCT06488950•Shanghai Juncell Therapeutics

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Third Affiliated Hospital of Naval Medical University

Shanghai, China

Key Dates

Start Date

April 1, 2023

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2027

Last Updated

December 16, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Solid TumorTumor Infiltrating LymphocytesTreatment Side EffectsEffects of Immunotherapy

Interventions

GC203 TIL(gene-edited TIL) or autologous TILs

BIOLOGICAL

Contacts

GC Clinical

CONTACT

086-18001759113 clinicaltrials@juncell.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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A Study of TIL in Advanced Solid Tumors (DFGD)

Inclusion Criteria

Exclusion Criteria

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