A Study of TIL in Advanced Solid Tumors (DFGD)

NCT06488950 | Recruiting Early Phase 1

• 1 other identifier: GC101/203-2023-DFGD-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 or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Conditions

Advanced Solid Tumor; Tumor Infiltrating Lymphocytes; Treatment Side Effects; Effects of Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Arm B

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: GC203 TIL(gene-edited TIL) or autologous TILs

Arm A

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: GC203 TIL(gene-edited TIL) or autologous TILs

Interventions

GC203 TIL(gene-edited TIL) or autologous TILs BIOLOGICAL

the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 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
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (1)

Third Affiliated Hospital of Naval Medical University

Shanghai, China

RECRUITING

Study Officials

• Qian Zhang

  Eastern Hepatobiliary Surgery Hospital

  PRINCIPAL INVESTIGATOR

• Wenlong Yu

  Eastern Hepatobiliary Surgery Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GC Clinical

CONTACT

086-18001759113; clinicaltrials@juncell.com

Study Design

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

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: April 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)