A Study of TIL in Advanced Solid Tumors (CZ)

NCT07294872 — Phase 1, Not yet recruiting, 30 participants, Shanghai Juncell Therapeutics

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

Registry	NCT07294872
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Shanghai Juncell Therapeutics (Industry); collaborators: Sichuan Cancer Hospital and Research Institute
Conditions	Solid Tumor, Adult
Interventions	GC101TIL (Biological)
Dates	start 2026-12-08 (estimated), primary completion 2027-09-20 (estimated), completion 2029-09-20 (estimated), first posted 2025-12-19, last updated 2026-08-05
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Arm B	Experimental	Biological: GC101TIL	GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Arm A	Experimental	Biological: GC101TIL	GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

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.

+Outcome measures

Primary outcomes

Adverse Events [6 month]: 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.

Secondary outcomes

Objective Response Rate (ORR) [Up to 36 months]: Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Disease Control Rate (DCR） [Up to 36 months]: Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Duration of Response (DOR) [Up to 36 months]: The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Progression-Free Survival (PFS) [Up to 36 months]: The time from TIL infusion until disease progression or death from any cause.
Overall Survival(OS) [Up to 36 months]: The time from TIL infusion until death from any cause.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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)

Facility	City	Country	Status
Sichuan Cancer Hospital & Institute, Sichuan Cancer Center	Chengdu	China

+Investigators

Huangming Hong, Principal investigator, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center