Active — Not RecruitingPhase 1

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

United States9 participantsStarted 2022-12-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Screening Pre-autoSCT: * 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. Exclusion Criteria for Screenin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 1 trial focused mainly on safety, so what does that mean for what we actually know so far about whether mosunetuzumab consolidation after a stem cell transplant helps keep the lymphoma from coming back?
2Since the trial is no longer actively enrolling new patients, is there any chance I could still be considered for participation, or are there similar follow-up studies using mosunetuzumab that might be open to me?
3The trial is specifically measuring how many people experience side effects serious enough to stop treatment — given that I'd already be recovering from a stem cell transplant, how would adding mosunetuzumab on top of that affect my recovery and overall treatment burden?
4Mosunetuzumab is a bispecific antibody, which works differently from standard post-transplant consolidation approaches — could you explain how it targets my type of B cell lymphoma and what unique risks that might carry compared to observation or other consolidation strategies after autoSCT?
5Given that this trial covers several aggressive B cell lymphoma subtypes including transformed lymphoma and high-grade B cell lymphoma, does the specific subtype I have affect whether this approach would even be relevant to discuss with my care team?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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)

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

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

Trial details

NCT IDNCT05412290

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More B Cell Lymphoma trials