Finding studies
Finding studies
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Study Coordinator
CONTACT
Lead
Seth Pollack
With
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
