Phase
Condition
Leukemia
Multiple Myeloma
Red Blood Cell Disorders
Treatment
Tocilizumab
Cevostamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 byIMWG criteria on or after their last dosing regimen
Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-Tor ADC therapy and are triple-class relapsed or refractory
Prior BCMA Bispecific Cohort: participants who have received a BCMA-targetingT-cell-dependent bispecific (TDB) antibody and are triple-class relapsed orrefractory
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 andaspirate 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 treatmentperiod and for at least 5 months after the final dose of cevostamab and for 3 monthsafter the last dose of tocilizumab was administered
For male participants: agreement to remain abstinent (refrain from heterosexualintercourse) or use a condom, and agree to refrain from donating sperm during thetreatment period and for at least 2 months after the final dose of tocilizumab (ifapplicable) to avoid exposing the embryo
Exclusion
Exclusion Criteria:
Inability to comply with protocol-mandated hospitalization
Pregnancy or breastfeeding, or intention of becoming pregnant during the study orwithin 5 months after the final dose of cevostamab or tocilizumab or within 3 monthsafter 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 dependentbi-specific antibody (TDB) antibody including non BCMA targeting TDB
Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC asanti-cancer therapy within 4 weeks before first study treatment, except for the useof non-myeloma therapy
Prior treatment with systemic immunotherapeutic agents
Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamabinfusion
Known treatment-related, immune-mediated adverse events associated with priorcheckpoint inhibitors
Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any otheranti-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 studytreatment
Prior allogeneic SCT
Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheralblood 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 suddendecompensation/deterioration in the setting of a tumor flare
History of other malignancy within 2 years prior to screening, except those withnegligible risk of metastasis or death, such as ductal carcinoma in situ notrequiring chemotherapy, appropriately treated carcinoma in situ of the cervix,non-melanoma skin carcinoma, low-grade, localized prostate cancer not requiringtreatment 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 abilityto 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 infectionat study enrollment, or any major episode of infection requiring treatment with IV (intravenous) antimicrobials where the last dose of IV antimicrobial was givenwithin 14 days prior to first study treatment
Active symptomatic COVID-19 infection at study enrollment or requiring treatmentwith IV antiviral where the last dose of IV antiviral treatment was given within 14days prior to first study treatment. Participants with active COVID-19 infectionmust have clinical recovery and two negative antigen tests at least 24 hours apartprior 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 neurotoxicitysyndrome (ICANS) with prior bispecific therapies
Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activationsyndrome (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 studytreatment or anticipation that such a live attenuated vaccine will be requiredduring the study
Treatment with systemic immunosuppressive medications, with the exception ofcorticosteroid treatment <= 10 mg/day prednisone or equivalent, within 2 weeks priorto first study treatment
History of illicit drug or alcohol abuse within 12 months prior to screening, in theinvestigator's judgment
Any medical condition or abnormality in clinical laboratory tests that, in theinvestigator's judgment, precludes the participant's safe participation in andcompletion of the study, or which could affect compliance with the protocol orinterpretation of results
Study Design
Connect with a study center
Calvary Mater Newcastle
Waratah, New South Wales 2298
AustraliaSite Not Available
Calvary Mater Newcastle; Hematology
Waratah, New South Wales 2298
AustraliaSite Not Available
St Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaSite Not Available
St Vincents Hospital
Melbourne, Victoria 3065
AustraliaSite Not Available
UZ Leuven Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
CHU NANTES - Hôtel Dieu
Nantes, 44093
FranceSite Not Available
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
Nantes, 44093
FranceSite Not Available
APHP - Hospital Saint Louis
Paris, 75475
FranceSite Not Available
CHU de Poitiers - La Miletrie
Poitiers, 86021
FranceSite Not Available
CHU de Poitiers - La Miletrie; Oncologie hematologique - Pole Regional de Cancerologie
Poitiers, 86021
FranceSite Not Available
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
Berlin, 12200
GermanySite Not Available
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, 20246
GermanySite Not Available
Klinik der Uni zu Köln
Köln, 50924
GermanySite Not Available
Klinik der Uni zu Köln; Klinik für Innere Medizin
Köln, 50924
GermanySite Not Available
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
Tübingen, 72076
GermanySite Not Available
Universitätsklinikum Würzburg
Würzburg, 97080
GermanySite Not Available
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, 97080
GermanySite Not Available
Hadassah Ein Karem Hospital
Jerusalem, 9112001
IsraelSite Not Available
Hadassah Ein Karem Hospital; Haematology
Jerusalem, 9112001
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 5262100
IsraelSite Not Available
Sheba Medical Center; Tel Hashomer
Ramat Gan, 5262100
IsraelSite Not Available
Sourasky Medical Centre
Tel-Aviv, 6423906
IsraelSite Not Available
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"
Bologna, Emilia-Romagna 40138
ItalySite Not Available
ASST PAPA GIOVANNI XXIII; Ematologia
Bergamo, Lombardia 24127
ItalySite Not Available
Asst Papa Giovanni Xxiii
Bergamo, Lombardia 24127
ItalySite Not Available
Fond. IRCCS Istituto Nazionale Tumori
Milano, Lombardia 20133
ItalySite Not Available
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia
Milano, Lombardia 20133
ItalySite Not Available
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette
Torino, Piemonte 10126
ItalySite Not Available
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette; Ematologia I
Torino, Piemonte 10126
ItalySite Not Available
Clinica Universitaria de Navarra; Servicio de Hematologia
Pamplona, Navarra 31008
SpainSite Not Available
Hospital Clínic i Provincial
Barcelona, 08036
SpainSite Not Available
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036
SpainSite Not Available
Clinica Universidad de Navarra Madrid; Servicio de Hematología
Madrid, 28027
SpainSite Not Available
Hospital Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid, 28041
SpainSite Not Available
Hospital Universitario la Fe; Servicio de Hematologia
Valencia, 46026
SpainSite Not Available
Mayo Clinic - Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045-2517
United StatesSite Not Available
Mayo Clinic-Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York 10029
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai (ISMMS); The Derald H. Ruttenberg Treatment Center
New York, New York 10029
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology - Nashville
Nashville, Tennessee 37203
United StatesSite Not Available
Methodist Hospital
San Antonio, Texas 78229
United StatesSite Not Available
Hunstman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
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