Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT07261657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
A Pilot Trial of N-803 in Patients With Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 received prior ACT using TCR-T cells.
III. Evaluate median progression-free survival (PFS) of patients with SS and MRCL treated with N-803 and that received prior ACT using TCR-T cells.
EXPLORATORY OBJECTIVES:
I. To perform detailed phenotypic analysis of the persisting transferred T cells in pre-dose and on-treatment leukapheresis samples of patients with SS and MRCL treated with N-803 and that received prior ACT using TCR-T cells.
II. To perform detailed analysis of other immunologic subsets, including natural killer (NK) cells and monocytes, following patients with SS and MRCL treated with N-803 and that received prior ACT using TCR-T cells.
OUTLINE:
Patients receive N-803 subcutaneously (SC) on day 1 of each cycle. Cycles repeat every 14 days for up to 52 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo leukapheresis during screening up until day 1 cycle 1 and during treatment on day 8 cycle 4. Patients also undergo computed tomography (CT), chest x-ray, or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 30 days.
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 received prior ACT using TCR-T cells.
III. Evaluate median progression-free survival (PFS) of patients with SS and MRCL treated with N-803 and that received prior ACT using TCR-T cells.
EXPLORATORY OBJECTIVES:
I. To perform detailed phenotypic analysis of the persisting transferred T cells in pre-dose and on-treatment leukapheresis samples of patients with SS and MRCL treated with N-803 and that received prior ACT using TCR-T cells.
II. To perform detailed analysis of other immunologic subsets, including natural killer (NK) cells and monocytes, following patients with SS and MRCL treated with N-803 and that received prior ACT using TCR-T cells.
OUTLINE:
Patients receive N-803 subcutaneously (SC) on day 1 of each cycle. Cycles repeat every 14 days for up to 52 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo leukapheresis during screening up until day 1 cycle 1 and during treatment on day 8 cycle 4. Patients also undergo computed tomography (CT), chest x-ray, or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 30 days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-08495 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STU00224911 | None | None | View | |
| NU 25S06 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |