Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Mosunetuzumab is a CD3xCD20 bispecific antibody administered intravenously in the consolidation setting after autologous stem cell transplant (autoSCT). 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. Patients will undergo PET-CT restaging around Day 100 post-autoSCT (approximately Cycle 3) and patients in complete response will continue mosunetuzumab for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients not in complete response will discontinue treatment and enter follow-up. All cycles are planned to be 21 days.

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.

Mosunetuzumab

Armin Ghobadi, M.D.

Camille Abboud, M.D.

Ramzi Abboud, M.D.

Nancy Bartlett, M.D.

Amanda Cashen, M.D.

Matthew Christopher, M.D., Ph.D.

Zachary Crees, M.D.

John DiPersio, M.D., Ph.D.

Todd Fehniger, M.D., Ph.D.

Brad Kahl, M.D.

Neha Mehta-Shah, M.D.

David Russler-Germain, M.D., Ph.D.

Peter Westervelt, M.D., Ph.D.

Feng Gao, Ph.D.

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.

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

A Pilot Study Evaluating the Safety and Efficacy of Mosunetuzumab Consolidation Therapy After Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

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.

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.

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.

Overall survival (OS) is defined as the time from day zero of autologous stem cell transplantation to death from any cause.

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.

Genentech, Inc.

Washington University School of Medicine

Infections

Symptoms and General Pathology

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, Mantle-Cell

Burkitt Lymphoma

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Hematologic Diseases

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Mantle Cell Lymphoma

Antibodies, Monoclonal

SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

SGN-CD19A

Ana Kostic, MD

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)

A Safety Study of SGN-CD19A for B-Cell Lymphoma

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

Seagen Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma	NCT05412290	B Cell Lymphoma Aggressive Lymp... Diffuse Large B... High-grade B-ce... Transformed Lym... Follicular Lymp...	Mosunetuzumab	18 Years -	Washington University School of Medicine
Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma	NCT05412290	B Cell Lymphoma Aggressive Lymp... Diffuse Large B... High-grade B-ce... Transformed Lym... Follicular Lymp...	Mosunetuzumab	18 Years -	Washington University School of Medicine
A Safety Study of SGN-CD19A for B-Cell Lymphoma	NCT01786135	Burkitt Lymphom... Lymphoma, Folli... Lymphoma, Large... Lymphoma, Mantl... Precursor B-cel...	SGN-CD19A	12 Years -	Seagen Inc.
A Safety Study of SGN-CD19A for B-Cell Lymphoma	NCT01786135	Burkitt Lymphom... Lymphoma, Folli... Lymphoma, Large... Lymphoma, Mantl... Precursor B-cel...	SGN-CD19A	12 Years -	Seagen Inc.

Spots Global Cancer Trial Database for follicular lymphoma grade 3