A Double-blind, Placebo-controlled Phase Ib Study Evaluating the Safety and Toxicity of Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)
Washington University School of Medicine
Summary
CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown. This is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of multiple myeloma with measurable disease by IMWG criteria. * Eligible for standard of care, FDA-approved BCMA CAR-T cell therapy with ciltacabtagene autoleucel. * Patients enrolling in the dose escalation stage must have received at least two prior lines of treatment and be penta-drug exposed (i.e. exposure to at least 5 active anti-myeloma drugs, excluding corticosteroids and melphalan and including, at minimum, a proteasome inhibitor, an immunomodulatory drug, and a CD38 monoclonal antibody). * Life expectancy ≥ 12 weeks per assessment from the enrollin…
Interventions
- DrugNT-I7
NT-I7 will be supplied by NeoImmuneTech Inc
- DrugPlacebo
Placebo will be supplied by NeoImmuneTech Inc
Location
- Washington University School of MedicineSt Louis, Missouri