MEN1703 (Dapolsertib hydrochloride) Alone and With Glofitamab for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the safety and anti-lymphoma activity of MEN1703 (Dapolsertib hydrochloride), alone or combined with glofitamab, in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. The trial includes two groups: one with patients who have not received prior anti-CD3xCD20 bispecific antibody therapy but have had at least two previous systemic treatments, and another with patients who have exhausted all standard treatment options after at least two prior treatments. This phase 2, open-label study aims to assess treatment effects and safety over a 12-month period. Participants in group 1 receive MEN1703 orally at either 150 mg daily for 7 days or 125 mg daily for 14 days within 21-day cycles, combined with glofitamab administered intravenously in a step-up dosing schedule, for up to 12 cycles. All group 1 participants also receive an intravenous infusion of obinutuzumab at the start. Group 2 participants receive MEN1703 alone, 125 mg orally daily for 14 days in 21-day cycles, continuing until disease progression. An optional randomized part allows group 1 patients to receive either the combination therapy or glofitamab alone. Throughout the study, participants undergo evaluations including CT or PET-CT scans to measure disease, regular monitoring for adverse events, and assessments of treatment impact on quality of life and patient-reported outcomes. Researchers will measure response rates, survival, and duration of response. Treatment adherence and safety are closely tracked over 12 months. The total study duration varies by group and individual disease progression, with ongoing monitoring to evaluate the treatments' effects.

MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)