A Study of TIL in Advanced Solid Tumors (DFGD)

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

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 or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor; Treatment Side Effects; Effects of Immunotherapy; Tumor Infiltrating Lymphocytes
• Intervention / Treatment: Biological: GC203 TIL(gene-edited TIL) or autologous TILs

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: GC Clinical; Phone Number: 086-18001759113; Email: clinicaltrials@juncell.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Third Affiliated Hospital of Naval Medical University
    • Contact: Xiaoyun Tai
    • Principal Investigator: Qian Zhang
    • Principal Investigator: Wenlong Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm B; 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: GC203 TIL(gene-edited TIL) or autologous TILs; the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample
Experimental: Arm A; 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: GC203 TIL(gene-edited TIL) or autologous TILs; the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	To characterize the safety profile of TILs in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR）	Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1	Up to 36 months
Duration of Response (DOR)	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	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
Objective Response Rate (ORR)	Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	Up to 36 months

Collaborators and Investigators

• Sponsor: Shanghai Juncell Therapeutics
• Collaborators: Eastern Hepatobiliary Surgery Hospital
• Investigators: Principal Investigator: Qian Zhang, Eastern Hepatobiliary Surgery Hospital; Principal Investigator: Wenlong Yu, Eastern Hepatobiliary Surgery Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GC101/203-2023-DFGD-ST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No