Actively Recruiting
Phase 2 Study of FDA-Approved Anti-CD19 CAR-T Therapy Followed by Mosunetuzumab and Polatuzumab for Treating Refractory or Relapsed Aggressive Non-Hodgkins Lymphoma
Led by Lazaros Lekakis · Updated on 2025-12-31
22
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving CAR-T Cell therapy, Mosunetuzumab, and Polatuzumab Vedotin for patients with refractory or relapsed aggressive Non-Hodgkins Lymphoma NHL. This phase 2 trial aims to see if this combination can reduce tumors in adults with specific types of aggressive NHL who have not responded to or have relapsed after prior treatments. Participants receive the study treatment in three phases an Induction Phase where Mosunetuzumab and Polatuzumab are given on scheduled days before CAR-T therapy a CAR-T Treatment Phase involving lymphodepleting chemotherapy followed by an infusion of CAR-T cells and a Consolidation Phase where Mosunetuzumab alone and then combined with Polatuzumab are administered at specified intervals after CAR-T therapy. Each drug is given via intravenous infusion at doses and days outlined by the protocol. During the study, participants will have regular clinic evaluations, laboratory tests, and imaging studies to monitor tumor response and treatment effects. Researchers will measure tumor response rates at 3 months and follow participants for up to 2 years to assess overall survival, disease progression, and treatment-related toxicities. Safety and side effects will be closely monitored throughout the study and follow-up periods, with total participation lasting until the final assessments are completed.
CONDITIONS
Brief Title
CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
Research Team
R
Robby Friedman
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