Phase II Study of Sequential CD19-directed CAR-T Cell Therapy Followed by Mosunetuzumab or Glofitamab Plus Obinutuzumab in Relapsed or Refractory Large B-cell Lymphomas

What this Trial Is About

This research aims to evaluate the safety and effectiveness of two experimental drug treatments, mosunetuzumab or the combination of obinutuzumab and glofitamab, given after CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma, including transformed follicular lymphoma. The study focuses on patients who have already received a CAR T-cell infusion and are seeking additional treatment options. It is a Phase II clinical trial sponsored by the Abramson Cancer Center at Penn Medicine. Participants are assigned to one of two groups Cohort 1 receives mosunetuzumab starting with a fractionated dosing schedule in cycle 1 followed by 60 mg and then 30 mg every 21 days for up to 17 cycles. Cohort 2 receives obinutuzumab 1000 mg on cycle 1 day 1 and glofitamab starting with a lower dose fractionated over two weeks in cycle 1 followed by 30 mg every 21 days for up to 12 cycles. All treatments are administered after standard-of-care CD19-directed CAR T-cell therapy. During the study, participants will undergo imaging scans such as PETCT, CT, or MRI to measure the lymphoma lesions before and after CAR T-cell therapy and during treatment cycles. Researchers will monitor responses using the Cheson 14 criteria to assess complete metabolic response at 24 weeks. Safety is evaluated by tracking dose-limiting toxicities within 63 days of glofitamab infusion. Additional follow-up includes measuring response duration for up to five years after the last bispecific antibody dose. Participants will be closely observed through laboratory tests and clinical assessments throughout their involvement.

CAR-T Followed by Bispecific Antibodies