A new clinical trial aims to assess the efficacy, safety, and tolerability of combined therapy with PF-07901801, tafasitamab, and lenalidomide in the management of patients with relapsing or refractory diffuse large B-cell lymphoma (DLBCL).
The trial is currently in the recruitment phase.
The multicenter, open-label, phase 1b/2 study aims to enroll approximately 70 patients with either refractory or relapsing DLBCL who are unable or unwilling to undergo autologous stem cell transplantation after receiving high-dose chemotherapy and are unable to receive chimeric antigen receptor T-cell therapy for any reason. All candidates must have adequate liver, kidney, and bone marrow function.
Read more about DLBCL therapies
All prior therapies must include at least 1 anti-CD20 antibody. Exclusion criteria include previous anti-CD47 or anti-CD19 therapy, previous use of immunomodulatory agents, autologous stem cell transplantation within 3 months before the beginning of the trial, and candidates with evidence of active infection.
In the 1b phase of the trial, participants will receive escalating doses of PF-07901801 along with tafasitamab and lenalidomide. Participants of the second phase will be randomized to receive the 2 doses of PF-07901801 established in phase 1b.
PF-0791801 will be given weekly for the first 3 cycles and every 2 weeks after that. Tafasitamab will be administered 5 times in the first 3 weeks of cycle 1. In cycles 2 and 3, it will be administered weekly and every 2 weeks after that. Lenalidomide will be taken orally daily for 21 days in the first 12 cycles.
The 1b phase aims to determine the dose-limiting toxicity after 28 days. Phase 2 aims to assess efficacy as the time interval between the beginning of treatment and disease progression, the start of a new therapy, or death.
Secondary endpoints of the study include frequency of adverse events in a 24-month interval, frequency of laboratory abnormalities, overall survival, progression-free survival, pharmacokinetic parameters of PF-07901801, and presence of antidrug antibodies or neutralizing antibodies.
The study is set to begin in December 2022. The estimated completion date is October 2025.
Effects of PF-07901801, tafasitamab, and lenalidomide in people with relapsed or refractory diffuse large B-cell lymphoma. ClinicalTrials.gov. November 23, 2022. Accessed November 30, 2022.