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Alkylating agents

Mosunetuzumab + Chemotherapy for B-Cell Lymphoma

Phase 1
Recruiting
Led By Nancy L Bartlett, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of diffuse 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 but no more than two prior lines 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 rituximab) will count as one line of systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing whether adding mosunetuzumab to chemotherapy may help patients with aggressive B cell lymphoma who have relapsed or are unresponsive to other treatments.

Who is the study for?
This trial is for adults with certain aggressive B cell lymphomas that have come back or didn't respond to initial treatments. They should be planning an autologous stem cell transplant and must not have had more than two prior chemotherapy lines. Participants need normal blood counts, no major recent surgeries, and can't be pregnant or breastfeeding. Those with autoimmune diseases, a history of severe allergies to monoclonal antibodies, active infections, or liver disease are excluded.Check my eligibility
What is being tested?
The study tests mosunetuzumab combined with platinum-based salvage chemotherapy (DHAX or ICE) in patients aiming for stem cell transplantation. It's designed to see if this combination is safe and potentially better than current chemoimmunotherapy options that use rituximab retreatment.See study design
What are the potential side effects?
Mosunetuzumab may cause side effects like infusion reactions (symptoms during or after the drug is given), low blood counts leading to increased infection risk, tiredness, and potential organ inflammation. The exact side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My B cell lymphoma has not responded to or has returned after specific chemotherapy.
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I've had 1-2 treatments with chemotherapy for lymphoma.
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I am planning to have a stem cell transplant after chemotherapy.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My platelet count is at least 75,000/mcL without recent transfusions.
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My hemoglobin level is at least 8 g/dL without needing a blood transfusion in the last week.
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My platelet count is at least 50,000 without recent transfusions.
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My lymphoma did not respond or has returned after specific chemotherapy.
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I've had 1 or 2 treatments with chemotherapy for lymphoma.
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I am planning to have a stem cell transplant after chemotherapy.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequencies and grades of treatment-emergent adverse events (TEAEs)
Rate of treatment delay or discontinuation due to treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Number of participants with complete response (CR)
Number of participants with partial response (PR)
Number of participants with progressive disease (PD)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Mosunetuzumab + ICEExperimental Treatment2 Interventions
3 cycles (cycle=21 days) of mosunetuzumab with ICE salvage chemotherapy (selected at the discretion of the treating physician). The first 3 patients in each arm will receive Dose Level 1 along with standard dosing of ICE. The rate of dose-limiting toxicities will determine whether the subsequent 3 patients in each arm are enrolled at Dose Level 1, or alternatively at Dose Level -1. For patients tolerating Cycle 1 of treatment, Cycles 2 and 3 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, and those achieving a CR (or PR, at their physician's discretion) will receive the Cycle 3 dose of mosunetuzumab and ICE, followed by standard of care stem cell mobilization and autoSCT. Patients with SD or PD after restaging will discontinue study treatment.
Group II: Arm A: Mosunetuzumab + DHAXExperimental Treatment2 Interventions
3 cycles (cycle=21 days) of mosunetuzumab with DHAX salvage chemotherapy (selected at the discretion of the treating physician). The first 3 patients in each arm will receive Dose Level 1 along with standard dosing of DHAX. The rate of dose-limiting toxicities will determine whether the subsequent 3 patients in each arm are enrolled at Dose Level 1, or alternatively at Dose Level -1. For patients tolerating Cycle 1 of treatment, Cycles 2 and 3 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, and those achieving a CR (or PR, at their physician's discretion) will receive the Cycle 3 dose of mosunetuzumab and DHAX, followed by standard of care stem cell mobilization and autoSCT. Patients with SD or PD after restaging will discontinue study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
ICE
2012
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
568,007 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,920 Previous Clinical Trials
2,293,684 Total Patients Enrolled
Nancy L Bartlett, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

DHAX (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05464329 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Arm A: Mosunetuzumab + DHAX, Arm B: Mosunetuzumab + ICE
Non-Hodgkin's Lymphoma Clinical Trial 2023: DHAX Highlights & Side Effects. Trial Name: NCT05464329 — Phase 1
DHAX (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464329 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the regulatory body approved Mosunetuzumab for therapeutic use?

"Due to a lack of evidence, our team assesses Mosunetuzumab's safety as a '1' on the 1-3 scale. This is because it has only completed Phase 1 clinical trials and thus there is still limited data regarding its efficacy or security."

Answered by AI

Are participants still being welcomed to join this research endeavor?

"This particular clinical trial, which was posted on December 31st 2022 and last updated November 22nd 2022 is not currently recruiting patients. Nevertheless, 1825 other trials remain open to participants at this current juncture."

Answered by AI

What primary outcomes is this trial aiming to ascertain?

"According to Genentech, Inc., the primary outcome being measured over a 13 week period is the Rate of treatment delay or discontinuation due to adverse events. Furthermore, secondary outcomes such as Number of participants with Progressive Disease (PD), total doses of Tocilizumab for managing Cytokine Release Syndrome (CRS), and Number of Participants with Partial Response (PR) will also be evaluated."

Answered by AI
~27 spots leftby Apr 2026