A Pilot Trial of N-803 in Patients With Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
Seth Pollack
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 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 involve active treatment with TCR-T…
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