NCT05260957

CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).

ML43165 - Single Arm Phase 2 Trial of an FDA Approved Anti-CD19 CAR-T Therapy Followed by Mosunetuzumab and Polatuzumab Consolidation for the Treatment of Refractory/Relapsed Aggressive NHL.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Lazaros Lekakis · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.

Conditions

• Refractory Non-Hodgkin Lymphoma
• Relapsed Non Hodgkin Lymphoma
• Aggressive Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	Induction Phase (Days -42 through -7): * 1 mg of Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -42. * 2 mg of Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -35. * 60 mg of Mosunetuzumab administered via intravenous (IV) infusion on (given as per treatment guidelines) on Days -28 and -7. Consolidation Phase (Day +1 through Day +90): 30 mg IV Mosunetuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Days +14, +35, +56 and +77.
DRUG	Polatuzumab	Induction Phase (Days -42 through -7): 1.8mg/kg of Polatuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Day -28. Consolidation Phase (Days +1 through +90): 1.8mg/kg of Polatuzumab administered via intravenous (IV) infusion (given as per treatment guidelines) on Days +35, +56 and +77.
BIOLOGICAL	CAR-T Cell Therapy	Participants will receive CAR-T Cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR-T Cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).

Timeline

• Start date: 2022-12-14
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2022-03-02
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study