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A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital) | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)

A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Hepatobiliary-Pancreatic Cancers

NCT05098197•Shanghai Juncell Therapeutics

View on ClinicalTrials.gov

Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced hepatobiliary-pancreatic cancers. Autologous 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

•1. Age: 18 years to 75 years;
•2. Histologically diagnosed as primary/relapsed/metastasized hepatobiliary cancer or pancreatic cancers;
•3. Expected life-span more than 3 months;
•4. Karnofsky≥60% or ECOG score 0-2;
•5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
•6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
•7. At least 1 evaluable tumor lesion;
•8. Hematology and Chemistry（within 7 days prior to enrollment）:
•* Absolute count of white blood cells≥2.5×10\^9/L;
•* Absolute count of neutropils≥1.5×10\^9/L;
+13 more criteria

Exclusion Criteria

•1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
•2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
•3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
•4. 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;
•5. Severe physical or mental diseases;
•6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
•7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
•8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
•9. Having received immunotherapy and developed irAE level greater than Level 3;
•10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
+3 more criteria

Locations (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

September 26, 2021

Primary Completion Date

September 25, 2026

Completion Date

September 25, 2026

Last Updated

December 11, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Liver CancersTumor Infiltrating LymphocyteTreatment Side EffectsEffects of ImmunotherapyAdvanced Pancreatic Cancers

Interventions

Tumor Infiltrating Lymphocyte

BIOLOGICAL

Contacts

Clinical GC

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 11, 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)

Inclusion Criteria

Exclusion Criteria

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