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A Study of TIL in Advanced Solid Tumors (DFGD)

NCT ID: NCT06488950

Last Updated: 2025-12-16

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

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2027-06-30

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 or biopsies 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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Advanced Solid Tumor Tumor Infiltrating Lymphocytes Treatment Side Effects Effects of Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm B

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

GC203 TIL(gene-edited TIL) or autologous TILs

Intervention Type BIOLOGICAL

the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample

Arm A

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

GC203 TIL(gene-edited TIL) or autologous TILs

Intervention Type BIOLOGICAL

the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample

Interventions

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GC203 TIL(gene-edited TIL) or autologous TILs

the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample

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

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

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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Qian Zhang

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Wenlong Yu

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Locations

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Third Affiliated Hospital of Naval Medical University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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GC Clinical

Role: CONTACT

[email protected]
086-18001759113

Facility Contacts

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Xiaoyun Tai

Role: primary

Other Identifiers

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GC101/203-2023-DFGD-ST

Identifier Type: -

Identifier Source: org_study_id