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About
The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in participants with relapsed or refractory DLBCL.
Full description
This is a randomized, multicenter, open-label, Phase 2 study of plamotamab combined with tafasitamab plus lenalidomide versus tafasitamab plus lenalidomide in adult participants with DLBCL who have relapsed after or are refractory to at least 1 prior line of therapy, which must have included multi-agent chemoimmunotherapy inclusive of an anti-cluster of differentiation (CD) 20 monoclonal antibody, and who are not candidates for autologous stem-cell transplantation (ASCT), refuse ASCT, or relapse after ASCT.
The study was planned to be performed sequentially, with Part 1A (Safety run-in, with a lower plamotamab dose), Part 1B (Safety run-in, with the target plamotamab dose) and Part 2 (Open-Label, randomized). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
Enrollment
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Inclusion criteria
Exclusion criteria
Exclusionary Previous and Current Treatment:
Previously received treatment with an anti-CD20 × anti-CD3 bispecific antibody (bsAb)
Anti-CD20 therapy (for example, rituximab) within 21 days prior to study entry
Participants who have, within 14 days prior study entry:
Participants who have had the following prior therapies or treatments:
Primary purpose
Allocation
Interventional model
Masking
3 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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