A Pilot Trial of N-803 in Patients With Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
Northwestern University
Summary
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.
Description
CO-PRIMARY OBJECTIVES: I. Assess whether nogapendekin alfa inbakicept (N-803) treatment in patients with SS and MRCL that received prior ACT using TCR-T cells expands rare persisting transferred TCR-T cells. II. Assess the safety of N-803 in patients with SS and MRCL that received prior ACT using TCR-T cells. SECONDARY OBJECTIVES: I. Assess for preliminary evidence of N-803 clinical activity by imaging in patients with SS and MRCL that received prior ACT using TCR-T cells. II. Evaluate 6-month progression free survival (PFS) of patients with SS and MRCL treated with N-803 and that have re…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 that can be assessed per medical history and/or discretion of the principal investigator. This includes the Food and Drug Administration (FDA) approved Afamitresgene autoleucel but also other products at the discretion of the principal investigator. * Note on references to Letetresgene Autoleucel and Afamitresgene Autoleucel: This study does not in…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- ProcedureLeukapheresis
Undergo leukapheresis
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- BiologicalNogapendekin Alfa Inbakicept
Given SC
- ProcedureX-Ray Imaging
Undergo chest x-ray
Location
- Northwestern UniversityChicago, Illinois