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

NCT05412290 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 202207137
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

B Cell Lymphoma; Aggressive Lymphoma; Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma; Transformed Lymphoma; Follicular Lymphoma Grade 3

Keywords

aggressive B cell lymphoma; consolidation post stem cell transplant; DLBCL; transformed B cell lymphoma; follicular lymphoma grade 3B

Outcome Measures

Primary Outcomes (3)

• Frequencies and grades of treatment-emergent adverse events (TEAEs)

  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.

  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)

• Rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs)

  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.

  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)

• Percentage of consented and enrolled patients completing at least 2 cycles of mosunetuzumab consolidation

  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.

  Evaluated from time of consent to completion of cycle 2 (each cycle is 21 days) of mosunetuzumab (estimated to be 13 weeks).

Secondary Outcomes (6)

• Progression-free survival (PFS)

  At 1 year post-autoSCT (estimated to be 1 year and 7 weeks).

• Progression-free survival (PFS)

  At 2 years post-autoSCT (estimated to be 2 years and 7 weeks).

• Overall survival (OS)

  At 1 year post-autoSCT (estimated to be 1 year and 7 weeks).

• Overall survival (OS)

  At 2 years post-autoSCT (estimated to be 2 years and 7 weeks).

• Percentage of patients requiring any tocilizumab doses for management of cytokine release syndrome (CRS)

  Up to approximately 6 months

Study Arms (1)

Consolidation Mosunetuzumab

EXPERIMENTAL

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.

Drug: Mosunetuzumab

Interventions

Mosunetuzumab DRUG

Mosunetuzumab is administered intravenously in a "step-up" dosing strategy. The doses will be 1 mg on C1D1, 2 mg on C1D8, 60 mg on C1D15, 60 mg on C2D1, and 30 mg for all doses following.

Also known as: RO7030816, BTCT4465A

Consolidation Mosunetuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of rCD20+ large B cell lymphoma, high-grade B cell lymphoma, transformed B cell lymphoma, primary mediastinal B cell lymphoma, or follicular lymphoma grade 3B.
• Planning to undergo autologous stem cell transplantation after two or more prior lines of therapy for lymphoma, including treatment for prior/underlying indolent B-NHL.
• At least 18 years of age.
• ECOG performance status ≤ 2
• The effects of mosunetuzumab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study treatment, and for 3 months following the final dose of mosunetuzumab. Specifically, women must remain abstinent or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for 3 months after the final dose of mosunetuzumab as applicable. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol with a female partner of childbearing potential or pregnant female partner must also agree to use adequate contraception prior to the study, for the duration of study treatment, and for 3 months following the final dose of mosunetuzumab.
• Ability to understand and willingness to sign an IRB approved written informed consent document.

You may not qualify if:

• Chemotherapy-resistant (stable or progressive disease) lymphoma at pre-autoSCT response assessment to salvage therapy.
• Known history of grade 3+ treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.
• Known history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH) if unrelated to prior lymphoma. If patient has a history of HLH secondary to prior lymphoma, all signs and symptoms of HLH secondary to prior lymphoma must be resolved for patient to be eligible for the study.
• Current or recent history (within the last 6 months) of clinically relevant CNS disease or pathology, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
• Prior allogeneic stem cell transplant.
• History of solid organ transplantation.
• History of severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies (mAbs).
• Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, including mannitol.
• History of erythema multiforme, grade ≥ 3 rash, or blistering following prior treatment with immunomodulatory derivatives.
• Known or suspected chronic active Epstein-Barr virus (EBV) infection.
• Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis.
• Active hepatitis B infection: Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (Anti-HBc) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation.
• Active hepatitis C infection: Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation.
• Known history of human immunodeficiency virus (HIV) positive status.
• History of progressive multifocal leukoencephalopathy (PML).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Armin Ghobadi, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armin Ghobadi, M.D.

CONTACT

314-747-8439; arminghobadi@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: December 22, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)