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A Study of TIL in Advanced Solid Tumors (CZ)

NCT ID: NCT07294872

Last Updated: 2025-12-19

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2029-09-20

Brief Summary

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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 and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Detailed Description

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Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm B

GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Group Type EXPERIMENTAL

GC101TIL

Intervention Type BIOLOGICAL

A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL.

Arm A

GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Group Type EXPERIMENTAL

GC101TIL

Intervention Type BIOLOGICAL

A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL.

Interventions

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GC101TIL

A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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;

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

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

Shanghai Juncell Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huangming Hong

Role: PRINCIPAL_INVESTIGATOR

Sichuan Cancer Hospital & Institute, Sichuan Cancer Center

Locations

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Sichuan Cancer Hospital & Institute, Sichuan Cancer Center

Chengdu, , China

Site Status

Countries

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China

Central Contacts

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Ying Cheng

Role: CONTACT

Phone: +8621-69110327

Email: [email protected]

Other Identifiers

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GC101/203-2025-CZ-ST

Identifier Type: -

Identifier Source: org_study_id