Actively Recruiting
N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
Led by Northwestern University · Updated on 2026-05-05
8
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This early phase I trial tests the safety and how well N-803 works in treating patients with synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) that is growing, spreading, or getting worse (progressive) after being treated with adoptive cellular therapy (ACT) using T-cell receptor therapy (T-CRT). Synovial sarcoma is a rare, slow-growing cancer that affects the soft tissues, like muscles or ligaments near the joints. Myxoid/round cell liposarcoma is a rare type of soft tissue sarcoma cancer that originates from fat cells usually in the arms and legs. N-803 is a type of immunotherapy-a treatment that helps patients' own immune system fight cancer, and it is made up of a natural protein called interleukin-15 (IL-15) that is important for growing and activating immune cells. Studies have shown that patients can progress after initially responding to TCR-T, so this trial will use N-803 to stimulate rare persisting cells (cells that survive treatment and cause treatment failure and disease relapse) to make them work better at attacking the cancer. Adoptive cell therapy is a type of therapy that uses a patient's own immune cells to fight cancer. T-cell receptor therapy is a type of ACT that can recognize better recognize and bind to protein in cancer cells. Giving N-803 may be safe and tolerable in patients with SS or MRCL.
CONDITIONS
Official Title
N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically or cytologically confirmed synovial sarcoma (SS) and/or myxoid/round cell liposarcoma (MRCL) who have progressed after ACT using TCR-T
- Patients must have been treated with a TCR-T product assessable by medical history or principal investigator discretion
- Patients must have measurable disease per RECIST version 1.1
- Patients must have shown clinical benefit on at least one scan after ACT using TCR-T (stable disease, partial or complete response)
- Patients must be aged 18 to 80 years at registration
- Patients must have a Karnofsky performance status over 70% or ECOG performance status less than 2
- Patients must be able to undergo leukapheresis per institutional standards
- Absolute lymphocyte count must be above institutional lower limit within 28 days before leukapheresis
- Absolute neutrophil count must be at least 1,000/mcL within 28 days before leukapheresis
- Hemoglobin must be at least 8.3 g/dL within 28 days before leukapheresis
- Platelets must be at least 40,000/mcL within 28 days before leukapheresis
- Total bilirubin must be within institutional upper limit of normal unless Gilbert's syndrome applies
- AST and ALT must be less than or equal to 1.5 times institutional upper limit of normal within 28 days before leukapheresis
- Alkaline phosphatase must be less than or equal to 2.5 times institutional upper limit of normal within 28 days before leukapheresis
- Serum creatinine must be less than or equal to 2.0 mg/dL or creatinine clearance at least 40 mL/min within 28 days before leukapheresis
- Patients of child-bearing potential and partners with sperm-producing capacity must agree to use adequate contraception during and 7 months after treatment
- Patients must have a negative pregnancy test if applicable
- Patients must be able and willing to sign informed consent and comply with study requirements
You will not qualify if you...
- Patients with unresolved adverse events from prior anticancer therapy above grade 1 except alopecia or neuropathy
- Patients with medical conditions preventing white blood cell donation
- Patients at high risk of bleeding or unable to take blood thinners as determined by investigator
- Patients who received other IL-15 treatments after TCR-T and before study treatment
- Patients with new or progressing brain metastases; stable treated brain metastases allowed
- Patients with significant cardiovascular disease including recent myocardial infarction or unstable arrhythmias
- Patients with history of severe allergic reactions to similar compounds or antibodies related to N-803
- Patients unable to safely receive subcutaneous N-803 injections due to physical or psychological reasons
- Patients with recent major surgery not fully healed as judged by investigator
- Patients with systemic autoimmune disease requiring treatment within 90 days
- Patients with history of organ transplant requiring immunosuppression or recent high-dose steroid use
- Patients with serious uncontrolled diseases or illnesses that could interfere with study or safety
- Patients with uncontrolled infections including active hepatitis B or C, HIV, or AIDS-related illness
- Patients with prior or concurrent malignancies that may interfere with safety or efficacy assessment except certain skin or cervical cancers
- Pregnant or nursing patients
- Patients needing concurrent anticancer treatments during the study
- Patients who used narrow therapeutic index CYP450 substrate drugs or QT-prolonging medications within 28 days before study drug
- Patients who had recent biologic therapies or chemotherapy within 28 days or radiation within 14 days before leukapheresis
- Patients unable to complete informed consent prior to study activities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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