Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

Description

The main purpose of this study is to learn about the safety of REGN5458 and to find out what is the best dose of REGN5458 to give to patients with multiple myeloma. An additional purpose is to look for any signs that REGN5458 can treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving REGN5458 * How REGN5458 works in the body * How much REGN5458 is present in the blood * How REGN5458 may work to treat cancer

Conditions

Multiple Myeloma

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Study Overview

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Study Details

Study overview

The main purpose of this study is to learn about the safety of REGN5458 and to find out what is the best dose of REGN5458 to give to patients with multiple myeloma. An additional purpose is to look for any signs that REGN5458 can treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving REGN5458 * How REGN5458 works in the body * How much REGN5458 is present in the blood * How REGN5458 may work to treat cancer

Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami Hospital/Sylvester Comprehensive, Miami, Florida, United States, 33136

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Atlanta

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States, 30322

Indianapolis

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States, 46202

Louisville

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

Ann Arbor

University of Michigan Health System, Ann Arbor, Michigan, United States, 48109

Detroit

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901

New York

The Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

New York

Columbia University Medical Center, Herbert Irving Pavilion, New York, New York, United States, 10032-3729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
  • 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol.
  • * Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either:
  • * Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria:
  • * Phase 2 (Cohorts 1 and 2):
  • * Phase 2 (Cohort 3):
  • 1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR
  • 2. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.
  • * Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy.
  • 1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients with known MM brain lesions or meningeal involvement 3. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) 4. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excludedand BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3.
  • 5. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneron Pharmaceuticals,

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

2032-06-24