A Study of TIL in Advanced Solid Tumors (CZ)

NCT07294872 | Not Yet Recruiting Phase 1

• 1 other identifier: GC101/203-2025-CZ-ST
• Study Type: interventional
• Target: 30
• 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 advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  To characterize the safety profile of GC101 TIL in patients with pancreatic ductal adenocarcinoma who were failed to standard treatment as assessed by incidence of adverse events.

  6 month

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to 36 months

• Disease Control Rate (DCR）

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Progression-Free Survival (PFS)

  Up to 36 months

• Overall Survival(OS)

  Up to 36 months

Study Arms (2)

Arm B

EXPERIMENTAL

GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Biological: GC101TIL

Arm A

EXPERIMENTAL

GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Biological: GC101TIL

Interventions

GC101TIL BIOLOGICAL

A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead
• Sichuan Cancer Hospital and Research Institute: collaborator

Study Sites (1)

Sichuan Cancer Hospital & Institute, Sichuan Cancer Center

Chengdu, China

Location

Study Officials

• Huangming Hong

  Sichuan Cancer Hospital & Institute, Sichuan Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Cheng

CONTACT

+8621-69110327; ying.cheng@juncell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 19, 2025
• Study Start (Estimated): May 8, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2029
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

CN (1)