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Large B-cell LymphomaPhase 1NCT05464329

Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

A Phase 1 study testing Mosunetuzumab, DHAX and ICE in people with Large B-cell Lymphoma and High-grade B-cell Lymphoma, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mosunetuzumab, DHAX and ICE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
3 Jan 2023to 16 Oct 2029
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 large, high-grade, or transformed B cell lymphoma or follicular lymphoma grade 3B that is refractory to or has relapsed after anti-CD20 mAb plus anthracycline-containing combination chemotherapy. A biopsy immediately prior to enrollment is not mandatory.
  • Must have received at least one prior line of systemic treatment containing conventional cytotoxic chemotherapy for lymphoma. Conventional cytotoxic chemotherapy with or without an anti-CD20 mAb for prior/underlying indolent NHL (with or without maintenance/extended-use anti-CD20 mAb) will count as one line of systemic therapy.
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Adequate hematologic function (unless due to underlying lymphoma per the investigator), defined as follows:
  • Absolute neutrophil count ≥ 1,000/mcL
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  • Platelets ≥ 75,000/mcL without platelet transfusion within 14 days prior to the first dose of mosunetuzumab
  • Hemoglobin ≥ 8 g/dL without red blood cell transfusion within 7 days prior to the first dose of mosunetuzumab
  • Patients with extensive bone marrow involvement by lymphoma and/or disease-related cytopenias (e.g., immune thrombocytopenia) may be enrolled if the following criteria are met:
  • Absolute neutrophil count ≥ 500/mcL
  • Platelet count ≥ 50,000/mcL without platelet transfusion within 14 days prior to the first dose of mosunetuzumab
  • No red blood cell transfusion within 7 days prior to the first dose of mosunetuzumab
  • Normal laboratory values:
  • Serum total bilirubin ≤ 1.5 x IULN (or ≤ 3 x IULN for patients with Gilbert's syndrome)
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Serum creatinine ≤ 1.5 x IULN or creatinine clearance ≥ 50 mL/min by Cockcroft-Gault
  • 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 (as defined in protocol) 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.

Who cannot join

  • Known history of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.
  • Known history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH).
  • Prior allogeneic stem cell transplant.
  • Treatment with radiotherapy within 2 weeks prior to the first dose of mosunetuzumab (otherwise one measurable lesion outside of the radiation field must remain).
  • Prior treatment with CAR-T cell therapy within 30 days of first dose of mosunetuzumab.
  • Any history of lymphomatous involvement of the CNS. Note: If CSF studies via lumbar puncture and/or neuroimaging are performed per physician discretion to rule out CNS involvement given active CNS signs or symptoms, these assessments should be completed within 6 weeks prior to study enrollment. There are no restrictions on the timing of CSF studies via lumbar puncture and/or neuroimaging performed for routine staging of patients without CNS signs or symptoms, or if performed for reasons unrelated to lymphoma evaluation.
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  • 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.
  • 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.
  • 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 formulation, including mannitol.
  • History of erythema multiforme, grade ≥ 3 rash, or blistering following prior treatment with immunomodulatory derivatives.
  • 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.
  • 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 (HBcAb) 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).
  • 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.
  • 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, interstitial lung disease (idiopathic, autoimmune, or drug-induced), pneumonitis (autoimmune or drug-induced), 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).
  • Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1 Day 1 or anticipation of a major surgical procedure during the study.
  • 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 Cycle 1 Day 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase Ib Study With Expansion Cohorts Evaluating the Safety and Efficacy of Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma. The hypothesis of this study is that mosunetuzumab can be safely combined with platinum-based salvage chemotherapy in this patient population, and that this approach may outperform chemoimmunotherapy approaches that instead incorporate rituximab retreatment. The enrolling physician's choice of the chemotherapy backbone will determine a patient's assigned study arm (Arm A = DHAX, Arm B = ICE). The two arms will accrue patients to phase Ib independently.

Being tested
Mosunetuzumab, DHAX, ICE
Keywords
Aggressive B cell lymphoma, Transformed B cell lymphoma, Follicular lymphoma grade 3B, Anti-CD3, Anti-CD20, Bispecific antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MosunetuzumabDrug

    Also called RO7030816, BTCT4465A

    Provided by Genentech.

  • DHAXDrug

    -Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.

  • ICEDrug

    -Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.

Study groups in NCT05464329
Study groupRoleWhat they receive
Arm A: Mosunetuzumab + DHAXExperimental* 4 cycles (cycle=21 days) of mosunetuzumab with DHAX salvage chemotherapy (selected at the discretion of the treating physician). * For patients tolerating Cycle 1 with step-up of treatment, Cycles 2 and beyond will consist of mosunetuzumab administered as a single dose on Day 1 along with DHAX. Patients will undergo PET-CT restaging prior to Cycle 3. Patients with SD or PD based on restaging after Cycle 2 will discontinue study treatment; further treatment will be administered at the discretion of the treating physician. Patients responding to study treatment based on restaging after Cycle 2 may receive up to two additional cycles of study treatment before consolidation therapy (e.g., autologous stem cell transplantation, chimeric antigen receptor T-cell therapy) at the discretion of the treating physician.
Receives: Drug: Mosunetuzumab; Drug: DHAX
Arm B: Mosunetuzumab + ICEExperimental* 4 cycles (cycle=21 days) of mosunetuzumab with ICE salvage chemotherapy (selected at the discretion of the treating physician). * For patients tolerating Cycle 1 with step-up of treatment, Cycles 2 and beyond will consist of mosunetuzumab administered as a single dose on Day 1 along with ICE. Patients will undergo PET-CT restaging prior to Cycle 3. Patients with SD or PD based on restaging after Cycle 2 will discontinue study treatment; further treatment will be administered at the discretion of the treating physician. Patients responding to study treatment based on restaging after Cycle 2 may receive up to two additional cycles of study treatment before consolidation therapy (e.g., autologous stem cell transplantation, chimeric antigen receptor T-cell therapy) at the discretion of the treating physician.
Receives: Drug: Mosunetuzumab; Drug: ICE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: From start of treatment through 30 days after administration of study treatment, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 16 weeks)

  2. Rate of treatment delay or 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: From start of treatment through 30 days after administration of study treatment, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 12 weeks)

Secondary outcomes (13)

  1. Number of participants with complete response (CR)

    -As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).

    Measured: After cycle 2 (each cycle is 21 days; estimated to be 42 days)

  2. Number of participants with partial response (PR)

    -As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).

    Measured: After cycle 2 (each cycle is 21 days; estimated to be 42 days)

  3. Overall response rate (ORR)

    • ORR: Number of participants with complete response (CR) and partial response (PR)
    • As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).

    Measured: After cycle 2 (each cycle is 21 days; estimated to be 42 days)

  4. Number of participants with stable disease (SD)

    -As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).

    Measured: After cycle 2 (each cycle is 21 days; estimated to be 42 days)

  5. Number of participants with progressive disease (PD)

    -As determined by PET-CT after Cycle 2 (PET2) of study treatment per Deauville 5-point scale (Lugano 2014 criteria).

    Measured: After cycle 2 (each cycle is 21 days; estimated to be 42 days)

  6. Progression-free survival (PFS)

    -Defined as the time from start of study therapy 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 24 months

  7. Progression-free survival (PFS)

    -Defined as the time from start of study therapy 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 36 months

  8. Progression-free survival (PFS)

    -Defined as the time from start of study therapy 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 48 months

  9. Overall survival (OS)

    -Overall survival (OS) is defined as the time from start of study therapy to death from any cause.

    Measured: At 24 months

  10. Overall survival (OS)

    -Overall survival (OS) is defined as the time from start of study therapy to death from any cause.

    Measured: At 36 months

  11. Overall survival (OS)

    -Overall survival (OS) is defined as the time from start of study therapy to death from any cause.

    Measured: At 48 months

  12. Percentage of participants requiring tocilizumab 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 12 weeks

  13. Number of total tocilizumab doses per participant 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 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start3 Jan 2023
  3. Primary completion2 Jan 2026
  4. Study completion16 Oct 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464329
Sponsor's protocol ID
202209113
Status last verified
Jan 2026
First submitted
14 Jul 2022
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mosunetuzumab, DHAX and ICE in people with Large B-cell Lymphoma and High-grade B-cell 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 18 inclusion and 39 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 8 Jan 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: From start of treatment through 30 days after administration of study treatment, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 16 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464329.

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 8 Jan 2026.

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