Immune cells take on sarcoma in early trial
NCT ID NCT04052334
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a treatment that uses a patient's own immune cells (called TILs) to fight soft tissue sarcoma. Nine young adults received chemotherapy to prepare their bodies, then an infusion of their own TILs plus high-dose IL-2 to boost the immune response. The main goal was to see if the treatment was safe and if the TILs could survive in the body.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Sep 2019
- Finished
-
Jun 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 39 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must fulfill all of the following criteria to be eligible for the study at the time of tumor resection and initiation of TIL expansion. * Stated willingness to comply with all study procedures and availability for the duration of the study * Participants must have metastatic, high-grade soft tissue sarcoma, all subtypes will be eligible * Residual measurable disease after resection of target lesion(s) for TIL growth * Eastern Cooperative Oncology Group (ECOG) 0 to 1. ECOG performance status of 0 to 1 will be inferred if the patient's level of energy is ≥ 50% of baseline. * Participants must have progressed on at least one prior standard of care treatment regimen for metastatic disease. * A negative pregnancy test (urine or serum) must be documented at screening for women of childbearing potential. * A MUGA scan (ejection fraction \> 50% is required) ≤ 6 months prior to lymphodepletion. * Pulmonary function tests should be completed ≤ 6 months prior to lymphodepletion and forced expiratory volume (FEV1) \> 65% or FVC \> 65% of predicted are required * Adequate renal, hepatic, and hematologic function, including creatinine of ≤ 1.7 gm/dL, total bilirubin ≤ 2.0 mg/dL, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dL, AST and ALT of less than 3 X institutional upper limit of normal, hemoglobin of 8 gm/dL or more, white blood cells of 3000 per mm\^3 and total granulocytes of 1000 per mm\^3 or more, and platelets of 100 000 per mm\^3 or more. * Participants must have a positive screening EBV antibody titre on screening test. * Participants that have had previously grown sterile, validated TILs under good manufacturing practice conditions meeting the above criteria are eligible using the previously established TIL product stored in the Cell Therapies Core facility for up to 2 years after harvesting. * Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the participant agrees to continue to use a method of contraception throughout the study such as: barrier (i.e. condom, diaphragm), hormonal, IUD, or sponge plus spermicide. * Prothrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the institutional upper limit of normal * Participants with echocardiogram (EKG) within 14 days of initiation of chemotherapy demonstrating no new rhythm, axis, or ST segment If new ST changes are present, patients may be included if cardiac stress test indicates no evidence of inducible cardiac ischemia. * Urinalysis within 14 days demonstrating no evidence of a urinary tract infection. * Participants with evidence of ongoing disease regression that is attributed to a therapy that is not part of the trial and that was administered after TIL harvest and expansion but prior to adoptive transfer of TILs should continue on prior therapy and may be treated with TIL only if their disease is stable or there is evidence of progressive disease. In this event as described above, the TIL will be frozen and stored for future use, in the event of progression, prior to the rapid expansion step. Exclusion Criteria: * Participants with active systemic infections requiring intravenous antibiotics, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system are excluded. * Participants that have completed a chemotherapy regimen given with the intent of lymphodepletion or cellular immunotherapy which included non-myeloablative lymphodepletion strategy. * Participants testing positive for HIV titer, hepatitis B surface antigen, human T-cell leukemia-lymphoma virus (HTLV) I or II antibody, or both rapid plasma regain (RPR) and fluorescent treponemal antibody (FTA) are excluded. Participants with hepatitis C antibody must have a negative (undetectable) viral load by polymerase chain reaction (PCR). * Participants who are pregnant or nursing are excluded. * Participants needing chronic immunosuppressive systemic steroids are excluded * Participants with autoimmune diseases that require immunosuppressive medications are excluded * Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated * Participants with central nervous system metastases will be excluded. * Inability to comprehend and give informed consent
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic soft tissue sarcoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Moffitt Cancer Center
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Pedaling through chemo: could exercise boost tumor blood flow?