A Study of GC203 TIL in Advanced Malignant Solid Tumors

NCT06375187 | Recruiting Phase 1

• 1 other identifier: GC203 TIL-ST-Ⅰ
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors

Conditions

Gynecologic Cancer; Breast Cancer; Solid Tumor; Gastrointestinal Cancer; Lung Cancer

Keywords

Adoptive cell therapy; Tumor Infiltrating Lymphocytes

Outcome Measures

Primary Outcomes (3)

• Maximal Tolerance Dose

  Up to Day 28

• Dose Limiting Toxicity

  Up to Day 28

• Adverse Events

  Maximum 360 days

Secondary Outcomes (6)

• Objective Response Rate

  Every 6 weeks for 12 months

• Duration of Response

  Every 6 weeks for 12 months

• Disease Control Rate

  Every 6 weeks for 12 months

• Progression-Free Survival

  Every 6 weeks for 12 months

• Overall Survival

  Every 6 weeks for 12 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)

Biological: Engineering Tumor Infiltrating Lymphocytes

Interventions

Engineering Tumor Infiltrating Lymphocytes BIOLOGICAL

A tumor sample is resected from each participant and cultured ex vivo to generate the engineered tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC203 TIL followed low-dose PD-1 antibody.

Also known as: GC203 TIL

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
• \. Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patients with advanced metastatic solid tumors with clear pathological diagnosis have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy \[including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery\]) , including but not limited to gynecological tumors (ovarian cancer, endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer, lung cancer.
• \. Patients have feasible tissue areas for tumor resection/puncture to generate GC203 TIL, the total volume of the tissue \> 400mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency therapy, oncolytic virus, etc.) or has progressed after local treatment; 5. At least one measurable target lesion before preconditioning, as defined by RECIST1.1.
• \. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• \. Patients must have an estimated life expectancy of ≥3 months. 8. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
• Absolute Neutrophil Count (ANC)≥1.0×10\^9/L;
• Absolute Lymphocyte Count(ALC)≥0.5×10\^9/L;
• Platelet≥80×10\^9/L；
• International Normalized Ratio（INR）≤1.5×ULN;
• Activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
• Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min
• Urinalysis: urine protein less than 2+, or 24-hour urine protein \<1g;
• Alanine aminotransferase(AST/SGOT) ≤3×ULN;
• Alanine aminotransferase (ALT/SGPT) ≤3×ULN;
• Total Bilirubin(TBIL)≤1.5×ULN； 9. Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.

You may not qualify if:

• Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
• Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
• Patients who have received systemic antitumor therapy within 4 weeks.
• Patients who have had another primary malignancy within the previous 5 years
• Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
• Patients with a history of hypersensitivity to any component of the study drugs
• Patients who are pregnant or breastfeeding.

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Huajun Jin, PhD

CONTACT

+8621-69110327; clinicaltrials@juncell.com

Xiaohua Wu, Phd

CONTACT

+862165675209; Wu.xh@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)