A Study of GC203 TIL in Advanced Solid Tumors (NF)

Shanghai Juncell Therapeutics

Status and phase

Not yet enrolling

Phase 1

Conditions

Solid Tumors, Adult

Treatments

Biological: GC203 TIL

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07256756

GC203-2025-NF-ST

Details and patient eligibility

About

This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.

Enrollment

8 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

have one the tumor resection for gene-edited GC203 TIL production and successfully produced；
Age: 18 years to 75years;
Histologically diagnosed as solid tumor;
Expected life-span more than 3 months;
ECOG score 0-1;
Test subjects have failed standard treatment regimens, and be willing to receive engineered GC203 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