Locally Advanced Gastrointestinal Stromal TumorPhase 2NCT07647068
Autologous Tumor Infiltrating Lymphocytes With Interleukin-2 for the Treatment of Locally Advanced, Recurrent or Metastatic Gastrointestinal Stromal Tumors
A Phase 2 study testing Aldesleukin, Biospecimen Collection and Chest Radiography in people with Locally Advanced Gastrointestinal Stromal Tumor and Metastatic Gastrointestinal Stromal Tumor, run by Joal Beane at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastrointestinal Stromal Tumor, Metastatic Gastrointestinal Stromal Tumor, Recurrent Gastrointestinal Stromal Tumor
- What is being tested?
- Aldesleukin, Biospecimen Collection and Chest Radiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2027to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measurable locally advanced, recurrent, or metastatic GIST
- Patients with locally advanced disease should be unresectable by conventional surgical approaches
- Patients with distant metastatic spread must be refractory to approved standard systemic therapies (such as imatinib and sunitinib) if they are eligible to receive these treatments
- Patients must be co-enrolled on the companion protocol Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies (institutional review board [IRB] #2024C0043), and have available TIL cultures for therapy
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible
- Greater than or equal to 18 years of age and less than or equal to age 75
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- Able to understand and sign the informed consent document
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Life expectancy of greater than three months
- Patients of both genders who are of child-bearing potential must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment
- Serology:
- Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be HCV ribonucleic acid (RNA) negative
- Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus
- Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
- White blood cells (WBC) ≥ 3000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 8.0 g/dl
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ to 3.5 times the upper limit of normal
- Serum creatinine ≤ to 1.6 mg/dl and calculated creatinine clearance (Crockcroft-Gault or 24-hour urine creatinine) ≥ 30 mL/min
- Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo)
- Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less
Who cannot join
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
- Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities)
- Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
- History of major organ autoimmune disease
- Concurrent systemic steroid therapy including physiologic replacement dosing of systemic steroids (i.e. prednisone ≤ 10 mg/day or equivalent) as well as topical or inhaled corticosteroids are not allowed
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- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- History of active coronary or ischemic symptoms
- Documented left ventricular ejection fraction (LVEF) of less than or equal to 45%
- Note: testing is required in patients with:
- Age ≥ 65 years old
- Clinically significant atrial and or ventricular arrhythmias including but not limited to:
- Atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, chest pain
- Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with:
- A prolonged history of cigarette smoking (20 pack [pk]/year of smoking within the past 2 years)
- Symptoms of respiratory dysfunction
- Patients who are receiving any other investigational agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Joal Beane, MD, 812-453-6178, Joal.Beane@osumc.edu
Joal Beane, MD
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic gastrointestinal stromal tumor (GIST) using the objective response rate (ORR).
SECONDARY OBJECTIVES:
- To further evaluate the efficacy of this therapy using complete response (CR) rate, duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
II. To characterize the safety profile of this therapy in patients with locally advanced, recurrent, or metastatic gastrointestinal stromal tumors (GIST).
OUTLINE:
Patients receive cyclophosphamide intravenously (IV) over 2 hours on days -8 and -7, fludarabine IV over 30 minutes on days -6 to -2 and TIL IV over 20-30 minutes on day 0 in the absence of disease progression or unacceptable toxicity. Starting within 24 hours of TIL infusion, patients receive aldesleukin IV over 15 minutes every 8 hours for up to 6 doses on days 0-3 in the absence of disease progression or unacceptable toxicity. Starting on day 1 or day 2, patients may receive filgrastim subcutaneously (SC) until neutrophil count > 1 x 10^9/L for 3 consecutive days or > 5 x 10^9/L. Patients with stable disease, partial response or recurrence may receive a second course of treatment. Patients also undergo chest x-ray at screening and urine and blood sample collection, computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) throughout the study. Additionally, patients may also undergo echocardiography or multigated acquisition scan (MUGA) at screening and may also undergo a second surgery to collect cells on study.
After completion of study treatment, patients are followed up at 4-6 weeks, 12 weeks, every 3 months for 3 visits, then every 6 months up to month 24.
- Conditions
- Locally Advanced Gastrointestinal Stromal Tumor, Metastatic Gastrointestinal Stromal Tumor, Recurrent Gastrointestinal Stromal Tumor, Refractory Malignant Gastrointestinal Stromal Tumor, Unresectable Malignant Gastrointestinal Stromal Tumor
- Being tested
- Aldesleukin, Biospecimen Collection, Chest Radiography, Computed Tomography, Cyclophosphamide
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldesleukinBiological
Also called 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo urine and blood sample collection
Chest RadiographyProcedure or surgery
Also called Chest X-ray
Undergo chest x-ray
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo echocardiography
FilgrastimBiological
Also called Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi
Given SC
FludarabineDrug
Also called Fluradosa
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo a second surgery
Tumor Infiltrating Lymphocyte TherapyBiological
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TIL, aldesleukin) | Experimental | Patients receive cyclophosphamide IV over 2 hours on days -8 and -7, fludarabine IV over 30 minutes on days -6 to -2 and TIL IV over 20-30 minutes on day 0 in the absence of disease progression or unacceptable toxicity. Starting within 24 hours of TIL infusion, patients receive aldesleukin IV over 15 minutes every 8 hours for up to 6 doses on days 0-3 in the absence of disease progression or unacceptable toxicity. Starting on day 1 or day 2, patients may receive filgrastim SC until neutrophil count > 1 x 10^9/L for 3 consecutive days or > 5 x 10^9/L. Patients with stable disease, partial response or recurrence may receive a second course of treatment. Patients also undergo chest x-ray at screening and urine and blood sample collection, CT, MRI or PET throughout the study. Additionally, patients may also undergo echocardiography or MUGA at screening and may also undergo a second surgery to collect cells on study. Receives: Biological: Aldesleukin; Procedure: Biospecimen Collection; Procedure: Chest Radiography; Procedure: Computed Tomography; Drug: Cyclophosphamide; Procedure: Echocardiography Test; Biological: Filgrastim; Drug: Fludarabine; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Procedure: Surgical Procedure; Biological: Tumor Infiltrating Lymphocyte Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Will be estimated by the proportion of patients with a best response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors criteria, with corresponding exact 95% confidence limit being reported.
Measured: Up to 24 months
Secondary outcomes (6)
CR rate
Will be estimated by the proportion of patients with a best response of complete response (CR) by Response Evaluation Criteria in Solid Tumors criteria
Measured: Up to 24 months
Duration of response
The distribution among patients achieving CR or PR will be characterized by median and quartiles.
Measured: Up to 24 months
Disease control rate
Measured: Up to 24 months
Progression-free survival
Will be estimated by the Kaplan-Meier method. The corresponding median survival times (with 95% confidence limits) will be determined, as will the cumulative percentage of patients remaining progression-free (and the cumulative percentage-alive) at selected time points after initial treatment (e.g., 3, 6,12, 18 months).
Measured: From the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), assessed up to 24 months
Overall survival
Will be estimated by the Kaplan-Meier method. The corresponding median survival times (with 95% confidence limits) will be determined, as will the cumulative percentage of patients remaining progression-free (and the cumulative percentage-alive) at selected time points after initial treatment (e.g., 3, 6,12, 18 months).
Measured: From the initial date of treatment to the recorded date of death, assessed up to 24 months
Incidence of adverse events
Will be described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade.
Measured: Up to 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Feb 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joal Beane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joal Beane, Ohio State University Comprehensive Cancer Center
- Investigators
- Joal Beane, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647068
- Sponsor's protocol ID
- OSU-22356
- Other IDs
- NCI-2026-03863, OSU-22356
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No