Phase 1 Study of SAR448501DR-0201 to Assess Safety and Effectiveness in Adults with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and activity of SAR448501DR-0201, a bispecific antibody, in adults with relapsed or refractory B-cell non-Hodgkin lymphoma who have not responded to at least two prior standard therapies. This open-label phase 1 study aims to find the optimal biological dose by assessing pharmacokinetics, pharmacodynamics, clinical effects, and immune response in a group of patients with this condition. Participants will receive SAR448501 for up to 52 weeks in different dose levels, with multiple ascending doses studied across several cohorts. The study includes an initial screening period lasting up to 28 days, followed by the treatment period, then a safety follow-up of about 28 days. Afterward, participants enter a long-term follow-up phase every three months that continues until withdrawal of consent, death, or study closure. During the study, patients will undergo evaluations to monitor adverse events, disease response, and drug levels in the body. Assessments include measuring tumor response, survival outcomes, and immune reactions. Researchers will also collect biopsy samples before and during treatment when safely possible. Overall, each participants involvement lasts about three years, including screening, treatment, safety monitoring, and long-term follow-up visits.

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma