Autologous Tumor Infiltrating Lymphocytes With Interleukin-2 for the Treatment of Locally Advance… (NCT07647068) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Autologous Tumor Infiltrating Lymphocytes With Interleukin-2 for the Treatment of Locally Advanced, Recurrent or Metastatic Gastrointestinal Stromal Tumors
United States59 participantsStarted 2026-08-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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 evaluat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial for GIST that hasn't started recruiting yet — given where I am in my treatment right now, does it make sense to wait for this trial to open, or should we be pursuing other options in the meantime?
2This trial involves removing tumor-infiltrating lymphocytes from my own tumor, growing them in a lab, and infusing them back along with interleukin-2 — how complex and physically demanding is that kind of treatment, and would my current condition make me a realistic candidate?
3The trial is measuring objective response rate as its main outcome — what does that mean in practical terms for GIST, and how does that compare to what I might expect from continuing or switching standard TKI therapy like imatinib or sunitinib?
4Since this is a Phase 2 study, what do we already know about the safety profile of tumor-infiltrating lymphocyte therapy with interleukin-2, and are there particular side effects I should understand before deciding whether to pursue this?
5My GIST is described as refractory or recurrent — does that history of prior treatment affect whether I'd likely be eligible for this trial once it does open, and are there steps I should take now to preserve eligibility?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate
Timeframe: Up to 24 months
Trial details
NCT IDNCT07647068
SponsorJoal Beane
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-12-31
Contact for this trial
The Ohio State University Comprehensive Cancer Center