AN OPEN-LABEL, MULTICENTER, PHASE I TRIAL EVALUATING THE SAFETY AND PHARMACOKINETICS OF ESCALATING DOSES OF BFCR4350A IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

NOT ENROLLING
Protocol # :
17-632
Conditions
Multiple Myeloma
Phase
I
Disease Sites
Multiple Myeloma
Principal Investigator
Laubach, Jacob, Peter
Site Research Nurses
Kendricken, Elizabeth
Nicholson, Taylor
Silva, Wendy, Ann

Trial Description

This is a phase I, multicenter, open-label, dose-escalation study of cevostamab administered
as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma
(R/R MM).

Eligibility Requirements

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy of at least 12 weeks

- Participants must have relapsed or refractory (R/R) multiple myeloma (MM) for which no
established therapy for MM is appropriate and available or be intolerant to those
established therapies

- Adverse events from prior anti-cancer therapy resolved to Grade < or = 1, except any
grade alopecia and/or peripheral sensory or motor neuropathy which must have resolved
to Grade < or = 2

- Measurable disease defined by laboratory test results

- Female participants of childbearing age must agree to remain abstinent or use reliable
contraceptive methods during the treatment period, and at least 5 months after last
dose of study drug. Women must refrain from breastfeeding during the same period.

- Male participants must agree to refrain from donating sperm, to abstain or use a
condom during the treatment period, and for at least 2 months after the last dose of
tocilizumab (if applicable).

Exclusion Criteria:

- Inability to comply with protocol-mandated hospitalization and activities restrictions

- Pregnant or breastfeeding, or planning to become pregnant during the study or within 5
months after the last dose of cevostamab or within 3 months after the last dose of of
tocilizumab (if applicable)

- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate
as anti-cancer therapy within 4 weeks before first infusion

- Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives
of the drug, whichever is shorter, before first infusion

- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 12 weeks
before first cevostamab infusion

- Known treatment-related, immune-mediated adverse events associated with prior
immunotherapeutic agents

- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other
anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the
drug, whichever is shorter, prior to first cevostamab infusion

- Autologous stem cell transplantation (SCT) within 100 days prior to first infusion

- Prior allogeneic SCT or solid organ transplantation

- Absolute plasma cell count exceeding 500/micro L or 5% of the peripheral blood white
cells

- History of autoimmune disease or of confirmed progressive multifocal
leukoencephalopathy

- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation
syndrome (MAS)

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
(or recombinant antibody-related fusion proteins)

- Patients with known history of amyloidosis (e.g., positive Congo Red stain or
equivalent in tissue biopsy)

- Patients with lesions in proximity of vital organs that may develop sudden
decompensation/deterioration in the setting of a tumor flare

- History of other malignancy that could affect compliance with the protocol or
interpretation of results

- Current or past history of central nervous system (CNS) disease, or CNS involvement by
MM

- Significant cardiovascular disease that may limit a patient's ability to adequately
respond to a CRS event

- Symptomatic active pulmonary disease requiring supplemental oxygen

- Within 14 days prior to first cevostamab infusion: known active bacterial, viral,
fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of
nail beds) at study enrollment, or any major episode of infection requiring treatment
with IV antibiotics within 4 weeks prior to first infusion

- 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, acute or chronic hepatitis C virus
(HCV) infection

- Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV)
infection

- Recent major surgery within 4 weeks prior to first infusion

- Human Immunodeficiency Virus (HIV) positive

- Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV
antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days,
prior to first study treatment

- Administration of a live, attenuated vaccine within 4 weeks before first cevostamab
infusion or anticipation that such a live attenuated vaccine will be required during
the study

- Received systemic immunosuppressive medications (including, but not limited to,
cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis
factor agents), with the exception of corticosteroid treatment <=10 mg/day prednisone
or equivalent within 2 weeks prior to first dose of cevostamab and, if applicable,
tocilizumab premedication prior to first dose of cevostamab

- History of illicit drug or alcohol abuse within 12 months prior to screening

- Any medical condition or laboratory test abnormality that precludes the participant's
safe participation in and completion of the study, or which could affect compliance
with the protocol or interpretation of results

17-632