A Study of GC203 TIL in Advanced Malignant Solid Tumors (KUNLUN-001)

A Phase I Study to Evaluate the Safety and Efficacy of Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)in Patients With Advanced Malignant Solid Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Gynecologic Cancer; Lung Cancer; Solid Tumor; Gastrointestinal Cancer
• Intervention / Treatment: Biological: Engineering Tumor Infiltrating Lymphocytes

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huajun Jin, PhD; Phone Number: +8621-69110327; Email: clinicaltrials@juncell.com
• Study Contact Backup: Name: Xiaohua Wu, Phd; Phone Number: +862165675209; Email: Wu.xh@fudan.edu.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Xiaohua Wu, PhD; Phone Number: +862164175590; Email: Wu.xh@fudan.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 1. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.

  2. 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.

  4. 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.

  6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  7. 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.

    10. Patients must have no contraindications for surgery or biopsy. 11. Patients have good compliance and be able to adhere to research access plans and other protocol requirements.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)	Biological: Engineering Tumor Infiltrating Lymphocytes; 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.; Other Names: GC203 TIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal Tolerance Dose	Up to Day 28
Dose Limiting Toxicity	Up to Day 28
Adverse Events	Maximum 360 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Assessment	Evaluate with EORTC QLQ-C30	Every 6 weeks for 12 months
Objective Response Rate	Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Duration of Response	Evaluate the efficacy endpoints of DoR by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Disease Control Rate	Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Progression-Free Survival	Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Overall Survival	Evaluate the efficacy endpoints of OS by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months

Collaborators and Investigators

• Sponsor: Shanghai Juncell Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Tumor Infiltrating Lymphocytes; Adoptive cell therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Lung Neoplasms; Breast Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: GC203 TIL-ST-Ⅰ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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