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NOT YET RECRUITING
NCT07647068
PHASE2

Autologous Tumor Infiltrating Lymphocytes With Interleukin-2 for the Treatment of Locally Advanced, Recurrent or Metastatic Gastrointestinal Stromal Tumors

Sponsor: Joal Beane

View on ClinicalTrials.gov

Summary

This phase II trial tests the effect of autologous tumor infiltrating lymphocytes (TILs) in combination with interleukin-2 (aldesleukin) in treating patients with gastrointestinal stromal tumors (GIST) that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Autologous TILs are made using the patient's own tumor cells collected from a previous surgery. Lymphocytes (a type of white blood cell) are a part of the immune system that helps the body fight infections. Lymphocytes are found in tumor tissue cells because they are working to attack the tumor. The cells from the tumor are grown in a lab to create more immune cells (lymphocytes). This may help the immune system find and destroy any remaining tumor cells. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes, that is made in the laboratory. Aldesleukin may help white blood cells and T cells regulate the immune response. Chemotherapy, such as cyclophosphamide and fludarabine, are given before receiving TIL to help kill tumor cells in the body and helps make room for the treatment. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving autologous TILs in combination with aldesleukin may be safe, tolerable, and/or effective in treating patients with locally advanced, recurrent or metastatic GIST.

Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Unresectable, Recurrent, or Metastatic Gastrointestinal Stromal Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2026-08-15

Completion Date

2027-12-31

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

Aldesleukin

Given IV

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

PROCEDURE

Chest Radiography

Undergo chest x-ray

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Surgical Procedure

Undergo a second surgery

BIOLOGICAL

Tumor Infiltrating Lymphocyte Therapy

Given IV

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States