Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma

Phase 1

Recruiting

• Conditions: Transformed Lymphoma; Aggressive Lymphoma; B Cell Lymphoma; Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma; Follicular Lymphoma Grade 3
• Interventions: Drug: Mosunetuzumab

• Registration Number: NCT05412290
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This phase 1 pilot study examines the feasibility and safety of mosunetuzumab after autologous stem cell transplant for patients with aggressive B cell lymphomas. Mosunetuzumab is an antibody that has been engineered to attach to two target cells in the immune system: T cells that normally perform tasks like killing virus-infected cells, and cancerous B cells. Mosunetuzumab has been designed to direct these T cells to kill the cancerous B cells instead.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Study Start: 2022-12-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24
• Primary Completion: 2027-01-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Consolidation Mosunetuzumab	Mosunetuzumab	Mosunetuzumab will be given in a step-up dosing schedule beginning on Day 49 after autoSCT on C1D1, C1D8, C1D15, and then Day 1 of all cycles thereafter (each cycle is 21 days). Patients will undergo PET-CT restaging on Day 100 after autoSCT. Those in complete response (CR) will continue mosunetuzumab from Cycle 3 Day 1 through Cycle 8 Day 1 administered at 30 mg IV. Patients not in CR at Day 100 PET-CT will discontinue study treatment.

Primary Outcome Measures

Name	Time	Method
Frequencies and grades of treatment-emergent adverse events (TEAEs)	Evaluated from start of study treatment through 30 days after last dose of mosunetuzumab, study discontinuation/termination, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 7 months)	Treatment-emergent adverse events (TEAE) are defined as adverse events possibly, probably, or definitely related to mosunetuzumab that occur on or after first dose of study treatment.
Rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs)	Evaluated from start of study treatment through 30 days after last dose of mosunetuzumab, study discontinuation/termination, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 7 months)	Treatment-emergent adverse events (TEAE) are defined as adverse events possibly, probably, or definitely related to mosunetuzumab that occur on or after first dose of study treatment.
Percentage of consented and enrolled patients completing at least 2 cycles of mosunetuzumab consolidation	Evaluated from time of consent to completion of cycle 2 (each cycle is 21 days) of mosunetuzumab (estimated to be 13 weeks).	Patients are consented and enrolled prior to autoSCT, and given the long delay from consent to treatment, this will allow evaluation of feasibility of this approach.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	At 2 years post-autoSCT (estimated to be 2 years and 7 weeks).	Overall survival (OS) is defined as the time from day zero of autologous stem cell transplantation to death from any cause.
Progression-free survival (PFS)	At 2 years post-autoSCT (estimated to be 2 years and 7 weeks).	Progression-free survival (PFS) is defined as the time from day zero of autologous stem cell transplantation to the first occurrence of disease progression as determined by the investigator with use of the Lugano Response Criteria or death from any cause.
Percentage of patients requiring any tocilizumab doses for management of cytokine release syndrome (CRS)	Up to approximately 6 months	Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses.
Number of tocilizumab doses per patient for management of cytokine release syndrome (CRS)	Up to approximately 6 months	Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States