B Cell LymphomaPhase 1NCT05412290
Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma
A Phase 1 study testing Mosunetuzumab in people with B Cell Lymphoma and Aggressive Lymphoma, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma, Aggressive Lymphoma, Diffuse Large B Cell Lymphoma
- What is being tested?
- Mosunetuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 3 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Diagnosis of CD20+large B cell lymphoma, high-grade B cell lymphoma, transformed B cell lymphoma, primary mediastinal B cell lymphoma, or follicular lymphoma grade 3B.
- Status post 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 (see Appendix A)
- 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.
- Adequate hematologic function defined as follows:
- Absolute neutrophil count ≥ 1,000/mcL without G-CSF use in past 7 days
- Platelets ≥ 75,000/mcL without TPO mimetic use in past 7 days
- Hemoglobin ≥ 8 g/dL without red blood cell transfusion in past 7 days
- Normal laboratory values:
- Serum total bilirubin ≤ 1.5 x IULN (or ≤ 3 x IULN for patients with Gilbert syndrome)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
- Measured or estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- 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.
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- 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).
- Other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following:
- Any of the following malignancies previously curatively treated: carcinoma in situ of the cervix, good-prognosis ductal carcinoma in situ of the breast, basal, or squamous cell skin cancer.
- Stage I melanoma, low grade, early stage localized prostate cancer, or any other previously treated malignancy that has been in remission without treatment for ≥ 2 years prior to enrollment.
- Active autoimmune disease requiring treatment.
- History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis:
- Patients with a remote history of, or well-controlled autoimmune disease, with a treatment free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the investigator.
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone are eligible.
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible.
- Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including but not limited to, significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
- Pregnant or lactating or intending to become pregnant during the study: Women of childbearing potential must have one negative serum pregnancy test result (minimum sensitivity, 25 mIU/mL) within seven days of enrollment.
- Clinical evidence of progressive lymphoma after auto-SCT.
- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to grade ≤ 1 per NCI CTCAE v 5.0 prior to Day 1 of Cycle 1.
- Treatment with systemic immunosuppressive medications, including but not limited to prednisone (>20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1. Note: The use of inhaled corticosteroids, mineralocorticoids for management of orthostatic hypotension, and single-dose dexamethasone for nausea or B symptoms is permitted.
- Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 1 week of Day 1 of Cycle 1.
- Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study. Patients must not receive live, attenuated vaccines (e.g., FluMist®) while receiving study treatment or after the last dose until B-cell recovery to the normal ranges.
- Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study.
- Any signs or symptoms of HLH secondary to lymphoma within 60 days prior to Day 1 of Cycle 1.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.
- 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).
- Other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following:
- Any of the following malignancies previously curatively treated: carcinoma in situ of the cervix, good-prognosis ductal carcinoma in situ of the breast, basal, or squamous cell skin cancer.
- Stage I melanoma, low grade, early stage localized prostate cancer, or any other previously treated malignancy that has been in remission without treatment for ≥ 2 years prior to enrollment.
- Active autoimmune disease requiring treatment.
- History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis:
- Patients with a remote history of, or well-controlled autoimmune disease, with a treatment free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the investigator.
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone are eligible.
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible.
- Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including but not limited to, significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
- Pregnant or lactating or intending to become pregnant during the study:
- Women of childbearing potential must have one negative serum pregnancy test result (minimum sensitivity, 25 mIU/mL) within seven days of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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
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
- Being tested
- Mosunetuzumab
- Keywords
- aggressive B cell lymphoma, consolidation post stem cell transplant, DLBCL, transformed B cell lymphoma, follicular lymphoma grade 3B
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosunetuzumabDrug
Also called RO7030816, BTCT4465A
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mosunetuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: At 1 year post-autoSCT (estimated to be 1 year and 7 weeks).
Progression-free survival (PFS)
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.
Measured: At 2 years post-autoSCT (estimated to be 2 years and 7 weeks).
Overall survival (OS)
Overall survival (OS) is defined as the time from day zero of autologous stem cell transplantation to death from any cause.
Measured: At 1 year post-autoSCT (estimated to be 1 year and 7 weeks).
Overall survival (OS)
Overall survival (OS) is defined as the time from day zero of autologous stem cell transplantation to death from any cause.
Measured: 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)
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.
Measured: Up to approximately 6 months
Number of tocilizumab doses per patient for management of cytokine release syndrome (CRS)
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.
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start22 Dec 2022
- Primary completion26 Sep 2026
- Study completion3 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Armin Ghobadi, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412290
- Sponsor's protocol ID
- 202207137
- Status last verified
- Oct 2026
- First submitted
- 6 Jun 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05412290
- Acronym / sponsor ID
- 202207137
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 26 Sep 2026 (actual)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consolidation Mosunetuzumab | Experimental | Drug: MosunetuzumabMosunetuzumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (62 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosunetuzumabAlso: RO7030816, BTCT4465AMosunetuzumab 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. | Drug | Consolidation Mosunetuzumab |
Primary outcome
Frequencies and grades of treatment-emergent adverse events (TEAEs)
Time frame: 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)
Time frame: 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
Time frame: 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.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: At 1 year post-autoSCT (estimated to be 1 year and 7 weeks).
Progression-free survival (PFS)
Time frame: At 2 years post-autoSCT (estimated to be 2 years and 7 weeks).
Overall survival (OS)
Time frame: At 1 year post-autoSCT (estimated to be 1 year and 7 weeks).
Overall survival (OS)
Time frame: 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)
Time frame: Up to approximately 6 months
Number of tocilizumab doses per patient for management of cytokine release syndrome (CRS)
Time frame: Up to approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Ghobadi, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mosunetuzumab in people with B Cell Lymphoma and Aggressive Lymphoma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 62 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies and grades of treatment-emergent adverse events (TEAEs) (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.