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A Study of GC203 TIL in Advanced Solid Tumors (NF)

NCT ID: NCT07256756

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-30

Study Completion Date

2028-11-30

Brief Summary

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This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.

Detailed Description

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Conditions

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Solid Tumors, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GC203 TIL

participants with advanced solid tumors using cryopreserved GC203 TIL

Group Type EXPERIMENTAL

GC203 TIL

Intervention Type BIOLOGICAL

A tumor sample is resected from each participant and cultured ex vivo to expand the population of engineered tumor infiltrating lymphocytes injection (GC203 TIL). After lymphodepletion, patients are infused GC203 TIL.

Interventions

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GC203 TIL

A tumor sample is resected from each participant and cultured ex vivo to expand the population of engineered tumor infiltrating lymphocytes injection (GC203 TIL). After lymphodepletion, patients are infused GC203 TIL.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* have one the tumor resection for gene-edited GC203 TIL production and successfully produced；
* Age: 18 years to 75years;
* Histologically diagnosed as solid tumor;
* Expected life-span more than 3 months;
* ECOG score 0-1;
* Test subjects have failed standard treatment regimens, and be willing to receive engineered GC203 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role collaborator

Shanghai Juncell Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ying Cheng

Role: CONTACT

Phone: +8621-69110327

Email: [email protected]

Other Identifiers

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GC203-2025-NF-ST

Identifier Type: -

Identifier Source: org_study_id