Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06375187

A Study of GC203 TIL in Advanced Malignant Solid Tumors

Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11

18

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Study of GC203 TIL in Advanced Malignant Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to sign informed consent and complete all study procedures
  • Between 18 and 75 years old at time of consent
  • Have advanced metastatic solid tumors with clear pathological diagnosis and failed standard therapies
  • Have feasible tissue for tumor resection/puncture to generate GC203 TIL with tissue volume > 400mm3
  • Have at least one measurable target lesion before preconditioning as per RECIST 1.1
  • Have ECOG performance status of 0 or 1
  • Have estimated life expectancy of at least 3 months
  • Meet specified hematologic, coagulation, hepatic, and renal function parameters
  • Women of child-bearing potential must have a negative pregnancy test and agree to use effective birth control
  • No contraindications for surgery or biopsy
  • Able to comply with study requirements and visits
Not Eligible

You will not qualify if you...

  • Participated in clinical trials of other drugs or biologics within 4 weeks before enrollment
  • History of allogeneic T cell therapy or gene-engineered autologous cell therapy within 1 year
  • Received systemic antitumor therapy within 4 weeks
  • Had another primary malignancy within the previous 5 years
  • Received live or attenuated vaccination within 28 days prior to treatment
  • History of hypersensitivity to any study drug components
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Actively Recruiting

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Research Team

H

Huajun Jin, PhD

CONTACT

X

Xiaohua Wu, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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