Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a multi-center, single-arm phase I clinical trial. A total of 26\~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/recurrent Advanced Solid Tumors

NCT05430360

Solid Tumor

RECRUITING PHASE1

Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer

NCT06519669

Adult Lung Cancer

RECRUITING NA

Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors

NCT05724732

Solid Tumor

UNKNOWN EARLY_PHASE1

GT201 Injection For The Treatment Of Advanced Solid Tumors

NCT06144671

Solid Tumor, Adult

RECRUITING PHASE1/PHASE2

GT201 Injection in Combination with Teraplizumab Injection for Treatment of Patients with Non-small Cell Lung Cancer

NCT06235242

Adult Non-small Cell Lung Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GT201 treatment group

Autologous tumor infiltrating lymphocyte injection

Group Type EXPERIMENTAL

GT201

Intervention Type BIOLOGICAL

Autologous tumor infiltrating lymphocyte injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GT201

Autologous tumor infiltrating lymphocyte injection

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

2.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.

3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion Criteria

* 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.

2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.

5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .

6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No