A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital)

NCT04960072 | Recruiting Early Phase 1

• 1 other identifier: GC101-2021-10hospital-GI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gastrointestinal tumors. 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.

Conditions

Gastrointestinal Tumor

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 1 year, and then every six months after that for up to 3 years)

  Up to 36 months

• Progression-Free Survival (PFS)

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

  Up to 36 months

Secondary Outcomes (3)

• Change in Quality of Life

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Overall Survival (OS)

  Up to 36 months

Study Arms (1)

Tumor Infiltrating Lymphocytes

EXPERIMENTAL

1x10\^9-5x10\^10 in vitro expanded autologous TILs will be infused i.v. to patients with relapsed/refractory malignant gastrointestinal tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Biological: Tumor Infiltrating Lymphocytes (TIL)

Interventions

Tumor Infiltrating Lymphocytes (TIL) BIOLOGICAL

Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.

Tumor Infiltrating Lymphocytes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years to 75 years;
• Histologically diagnosed as primary/relapsed/metastasized gastrointestinal tumors ;
• Expected life-span more than 3 months;
• Karnofsky≥60% or ECOG score 0-2;
• Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
• Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
• At least 1 evaluable tumor lesion;
• 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;
• Absolute count of lymphocytes ≥0.7×109/L；
• Platelet count≥100×10\^9；
• hemoglobin≥90 g/L;
• Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
• International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);

You may not qualify if:

• Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
• Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
• 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.
• 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;
• Severe physical or mental diseases;
• Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
• Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
• History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
• Having received immunotherapy and developed irAE level greater than Level 3;
• 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);
• Females in pregnancy or lactation;
• History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
• Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Officials

• Qing Xu

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GC Clinical

CONTACT

18001759113; clinicaltrials@juncell.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: June 30, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)