What is GC101 tumor infiltrating lymphocyte (TIL) therapy studying for advanced hepatobiliary and pancreatic cancers?

GC101 TIL therapy is being studied to assess its safety and effectiveness in treating advanced liver and pancreatic cancers. Researchers want to see how well the therapy controls disease and affects survival. The study is sponsored by Shanghai Juncell Therapeutics and focuses on patients who have limited treatment options.

Who may be eligible for this advanced hepatobiliary-pancreatic cancer clinical trial?

Adults aged 18 to 75 years with diagnosed primary, relapsed, or metastatic hepatobiliary or pancreatic cancers may be eligible. Patients must have failed standard treatments or have no available standard options and have tumor tissue suitable for TIL collection. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced hepatobiliary-pancreatic cancer clinical trial?

Study-related care, including the TIL therapy and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for these potential costs.

Actively Recruiting

Early Phase 1

Age: 18Years - 75Years

All Genders

ID05098197

Study of GC101 Tumor Infiltrating Lymphocyte Therapy for Adults with Advanced Hepatobiliary and Pancreatic Cancers

Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of tumor infiltrating lymphocyte TIL therapy for patients with advanced hepatobiliary and pancreatic cancers. This early phase 1 study involves patients who have primary, relapsed, or metastasized liver or pancreatic cancers. The goal is to evaluate how well this treatment works and its impact on disease progression and survival over up to 36 months. Participants receive an infusion of their own expanded TILs, ranging from 1x109 to 5x1010 cells, after a non-myeloablative lymphodepletion treatment that includes a single dose of hydroxychloroquine 600 mg and cyclophosphamide. The TILs are prepared from tumor tissue or malignant fluids collected through biopsy or surgery. The infusion is given intravenously over 30 to 120 minutes. During the study, participants will be monitored for up to 36 months with regular assessments of adverse events, tumor response, disease control, duration of response, progression-free survival, and overall survival. Researchers will also evaluate changes in quality of life. Patients must be able to follow the visit schedule and attend follow-ups to assess treatment effects and safety over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 18 and 75 years
Histologically confirmed primary, relapsed, or metastatic hepatobiliary or pancreatic cancer
Expected life span of more than 3 months
Karnofsky score 60% or higher, or ECOG performance status 0 to 2
Failed standard treatments or no available standard regimens
Tumor regions suitable for biopsy or resection, or malignant body fluid for TIL isolation
At least one tumor lesion that can be evaluated
Hematology and chemistry lab values within 7 days prior to enrollment meeting specified thresholds
No contraindications to operation or biopsy
Willingness to use effective contraception if of child-bearing potential during and up to one year after lymphodepletion
No tumor-targeting therapies within 28 days before TIL collection
Ability to understand and sign informed consent
Willingness to adhere to follow-up visit schedule and study requirements

You will not qualify if you...

Need for glucocorticoid treatment with prednisone over 15 mg daily or immunomodulatory treatment for autoimmune diseases
Forced expiratory volume in 1 second less than 2L or lung diffusion capacity less than 40%
Severe cardiovascular conditions including NYHA class III or IV heart failure, uncontrolled low blood pressure, significant coronary artery disease, or ejection fraction below 35%
HIV infection, active hepatitis B or C, syphilis infection
Severe physical or mental illness
Active systemic infection or positive blood cultures
Current or recent treatment (within one month) with other medicines, biologics, chemotherapy, or radiotherapy
Allergy history to chemicals or biologics similar to cell therapy
History of severe immune-related adverse events from prior immunotherapy greater than grade 3
Unresolved adverse events from previous anti-tumor treatment above grade 1 (except alopecia)
Pregnancy or breastfeeding
History of organ transplantation, stem cell transplantation, or renal replacement therapy
Other severe systemic diseases or conditions deemed inappropriate by researchers for study participation

Research Team

Clinical GC

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Study of GC101 Tumor Infiltrating Lymphocyte Therapy for Adults with Advanced Hepatobiliary and Pancreatic Cancers

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria