A Study of TIL in Advanced Solid Tumors (CZ)

Shanghai Juncell Therapeutics

Status and phase: Begins enrollment in 3 months; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Biological: GC101TIL

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07294872

GC101/203-2025-CZ-ST

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm B

Experimental group

Description:

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

Treatment:

Biological: GC101TIL

Arm A

Experimental group

Description:

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

Treatment:

Biological: GC101TIL