drugset / Trial / NCT07791498

Teclistamab In Waldenstrom's Macroglobulinemia

NCT07791498 ↗

Phase 2 Not yet recruiting 24 enrolled Massachusetts General Hospital Johnson & Johnson · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2027-02-19
Primary completion
2027-09-01
Completion
2029-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Teclistamab Monoclonal antibody — Subcutaneous