New hope for Hard-to-Treat myeloma: cevostamab trial underway
NCT ID NCT05535244
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study tests a drug called cevostamab in 90 people with multiple myeloma that has returned or not responded to prior treatments, including BCMA-targeted therapies. Participants receive cevostamab by IV every 3 weeks. The goal is to see if the drug can shrink tumors and how safe it is. Side effects like cytokine release syndrome will be managed with another drug, tocilizumab.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cevostamab (a drug given by IV infusion)
- What this could lead to
- If successful, cevostamab could offer a new treatment option for people with multiple myeloma that has stopped responding to other BCMA-targeted therapies.
- What could go wrong
- This is an early-phase trial with only 90 participants, so results may not apply to everyone. Side effects like cytokine release syndrome are possible and will be managed with tocilizumab.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented diagnosis of MM based on standard International Myeloma Working Group (IMWG) criteria * Evidence of progressive disease based on investigators determination of response by IMWG criteria on or after their last dosing regimen * Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T or ADC therapy and are triple-class relapsed or refractory * Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting T-cell-dependent bispecific (TDB) antibody and are triple-class relapsed or refractory * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy is at least 12 weeks * Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate samples as detailed in the protocol * Resolution of AEs from prior anti-cancer therapy to Grade =\< 1 * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 5 months after the final dose of cevostamab and for 3 months after the last dose of tocilizumab was administered * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 2 months after the final dose of tocilizumab (if applicable) to avoid exposing the embryo Exclusion Criteria: * Inability to comply with protocol-mandated hospitalization * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of cevostamab or tocilizumab or within 3 months after the last dose of tocilizumab (if applicable) * Prior treatment with cevostamab or another agent with the same target * Prior BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent bi-specific antibody (TDB) antibody including non BCMA targeting TDB * Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy * Prior treatment with systemic immunotherapeutic agents * Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab infusion * Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors * Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment * Autologous stem cell transplantation (SCT) within 100 days prior to first study treatment * Prior allogeneic SCT * Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral blood white cells * Prior solid organ transplantation * History of autoimmune disease * History of confirmed progressive multifocal leukoencephalopathy * History of severe allergic or anaphylactic reactions to mAb therapy * Known history of amyloidosis * Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare * History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death, such as ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer not requiring treatment or appropriately treated Stage I uterine cancer * Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM * Significant cardiovascular disease that may limit a potential participant's ability to adequately respond to a cytokine release syndrome (CRS) event * Symptomatic active pulmonary disease or requiring supplemental oxygen * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV (intravenous) antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment * Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Participants with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment * Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or cytomegalovirus (CMV) PCR prior to first study treatment * Known or suspected chronic active EBV infection * Known history of Grade \>=3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies * Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) * Recent major surgery within 4 weeks prior to first study treatment * Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection * Acute or chronic hepatitis C virus (HCV) infection * Known history of human immunodeficiency virus (HIV) seropositivity * Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study * Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment \<= 10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment * History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment * Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette
Turin, Piedmont, 10126, Italy
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APHP - Hospital Saint Louis
Paris, 75475, France
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Asst Papa Giovanni Xxiii
Bergamo, Lombardy, 24127, Italy
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CHU NANTES - Hôtel Dieu
Nantes, 44093, France
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CHU de Poitiers - La Miletrie
Poitiers, 86021, France
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Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Fond. IRCCS Istituto Nazionale Tumori
Milan, Lombardy, 20133, Italy
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Hadassah Ein Karem Hospital
Jerusalem, 9112001, Israel
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Hospital Clínic i Provincial
Barcelona, 08036, Spain
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Hospital Univ. 12 de Octubre
Madrid, 28041, Spain
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Hunstman Cancer Institute
Salt Lake City, Utah, 84112, United States
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Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, 10029, United States
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Klinik der Uni zu Köln
Cologne, 50924, Germany
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Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
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Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138, Italy
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Sheba Medical Center
Ramat Gan, 5262100, Israel
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Sourasky Medical Centre
Tel Aviv, 6423906, Israel
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St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
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Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
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UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
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University of Colorado
Aurora, Colorado, 80045-2517, United States
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University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
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Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, 20246, Germany
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Universitätsklinikum Würzburg
Würzburg, 97080, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?