Massachusetts General Hospital
The goal of this clinical trial is to assess the efficacy of teclistamab in participants with relapsed or refractory Waldenstrom's macroglobulinemia who have received prior therapy. This study also aims to assess the safety and tolerability of teclistamab, how quickly and to what extent response is seen in participants, how strong any clinical benefit of teclistamab might be, and determine the response to teclistamab based on the combination of MY88 and CXCR4 mutations. The main questions it aims to answer are: * Will teclistamab be effective in treating Waldenstrom's macroglobulinemia? * By targeting BCMA with teclistamab, will direct Waldenstrom's macroglobulinemia tumor death occur? Participants will receive teclistamab for up to 9 cycles (cycle 1 is 14 days, cycles 2-5 are 28 days, and cycles 6-9 are 56 days) or until their disease progresses, another illness or change in their condition prevents them from further receiving the treatment, they experience unacceptable side effects, they demonstrate an inability or unwillingness to receive the medication regimen, or they decide to withdraw from the study. Participants will be followed for up to 3 years from the last treatment.
This is an open label phase II study that will enroll 24 patients with relapsed or refractory Waldenstrom's macroglobulinemia after one or more lines of systemic therapy for WM, including an anti-CD20 monoclonal antibody-containing regimen or a BTK inhibitor. This research study is evaluating a less frequent and shorter dosing schedule of teclistamab compared to the approved dosing schedule for individuals with multiple myeloma, which includes more frequent dosing in early treatment cycles and continuing to receive teclistamab until disease progression or unacceptable side effects occur. Johns…
Inclusion Criteria: * Clinicopathological diagnosis of WM per IWWM2 criteria. * Meeting criteria for treatment per IWWM2 criteria. * Relapsed or refractory WM with at least 1 prior line of treatment, including an anti-CD20 monoclonal antibody containing regimen or a BTK inhibitor. * Patients should have received a prior BTK inhibitor (except for contraindications such as bulky disease, amyloidosis, significant medication interactions, or a history of severe bleeding). * Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmaph…
Subcutaneous injection into the abdomen received on days 1, 4, and 7 of the first 14-day cycle, then every week for up to four 28-day cycles, and then for up to four 56-day cycles, with a maximum of 9 cycles.