Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Aug 31, 2030
  • participants needed
    256
  • sponsor
    Regeneron Pharmaceuticals
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Updated on 24 October 2022
See if I qualify
cancer
measurable disease
dexamethasone
lenalidomide
bortezomib
carfilzomib
refractory multiple myeloma
okt3

Summary

The primary objective of the study is to assess the safety and tolerability, and identify the recommended dose of REGN5458 for the expansion portion in combination with each one of the following cancer treatments:

  • Daratumumab plus dexamethasone (Dd: Cohort 1)
  • Carfilzomib plus dexamethasone (Kd: Cohort 2)
  • Lenalidomide plus dexamethasone (Rd: Cohort 3)
  • Bortezomib plus dexamethasone Vd: (Cohort 4)

The secondary objectives of the study for each cohort are:

  • To assess the preliminary anti-tumor activity by International Myeloma Working Group (IMWG) criteria
  • To measure the depth and durability of response
  • To evaluate the pharmacokinetic (PK) properties of REGN5458 when given in combination with Dd, Kd, Rd, and Vd
  • To evaluate immunogenicity of REGN5458 when given in combination with Dd, Kd, Rd, and Vd
  • Describe the overall survival (OS) of the participants

Details
Condition Multiple Myeloma
Treatment Dexamethasone, Lenalidomide, Bortezomib, Daratumumab, Carfilzomib, REGN5458
Clinical Study IdentifierNCT05137054
SponsorRegeneron Pharmaceuticals
Last Modified on24 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Relapsed/refractory multiple myeloma (MM): Progression of disease following at least 3 lines of therapy, or least 2 lines of therapy and either
prior exposure to at least 1 anti-CD38 antibody, 1 IMiD and 1 PI or
double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD. Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated. However, patients cannot be refractory to an anti-CD38 antibody-containing regimen. In addition, patients must have a 6-month washout from prior anti-CD38 antibody therapy
Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the
approved full dose. However, patients cannot be refractory to a carfilzomib-containing
regimen. In addition, patients must have a 6-month washout from prior carfilzomib
therapy
Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the
approved full dose. However, a patient cannot be refractory to any combination regimen
that included 25 mg of lenalidomide. In addition, patients must have a 6-month washout
from prior lenalidomide therapy (including maintenance therapy)
Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the
approved full dose. However, a patient cannot be refractory to any combination regimen
including the approved induction dose of bortezomib. In addition, patients must have a
-month washout from prior bortezomib therapy
Participants must have measurable disease and as defined in the protocol for response
assessment as per the 2016 International Myeloma Working Group (IMWG) response
assessment criteria
Adequate creatinine clearance, hematologic and hepatic functions, as defined in
protocol
Life expectancy of at least 6 months

Exclusion Criteria

Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma
associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma)
or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein
and skin changes)
Participants with known MM brain lesions or meningeal involvement
Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days
prior to first administration of study drug regimen, whichever is shorter
History of allogeneic stem cell transplantation, or autologous stem cell
transplantation within 12 weeks of the start of study drug regimen
For participants with peripheral neuropathy grade ≥2 receiving bortezomib-based
treatment (cohort 4 only)
Prior treatment with BCMA-directed immunotherapies, including any chimeric antigen
receptor T cell (CAR T) therapy (Note: BCMA antibody-drug conjugates are not excluded)
History of neurodegenerative condition or central nervous system (CNS) movement
disorder or participants with a history of seizure within 12 months prior to study
enrollment are excluded
Live or attenuated vaccination within 28 days prior to first study drug regimen
administration with a vector that has replicative potential
Cardiac ejection fraction <40% by echocardiogram (Echo) or multigated acquisition
(MUGA) scan
Pregnant or breasting feeding women or women of childbearing potential (WOCBP) with
positive pregnancy test result
WOCBP or men who are unwilling to practice highly effective contraception prior to the
initial dose/start of the first treatment, during the study, and for at least 6 months
after the last dose
NOTE: Other protocol defined inclusion/exclusion criteria apply
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okt3

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