Phase 1, first-in-human, dose escalation study of JNJ-79635322, a trispecific antibody, in participants with relapsed or refractory multiple myeloma or previously treated AL amyloidosis

Janssen Research & Development, LLC0 sites140 target enrollmentJanuary 3, 2023

ConditionsRelapsed or refractory multiple myeloma or previously treated amyloid light-chain (AL) amyloidosis Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or refractory multiple myeloma or previously treated amyloid light-chain (AL) amyloidosis
Sponsor: Janssen Research & Development, LLC
Enrollment: 140
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 3, 2023

End Date

October 13, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Eligibility Criteria

Inclusion Criteria

•Current inclusion criteria as of 02/01/2024:
•For participants with relapsed or refractory multiple myeloma:
•1\. Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
•2\. Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti\-CD38\-based therapy for the treatment of multiple myeloma (MM), and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti\-CD38\-based therapy regardless of prior lines of therapy
•3\. Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
•4\. Have measurable disease at screening as defined by at least 1 of the following:
•4\.1\. Serum M\-protein level \=0\.5 g/dL; or
•4\.2\. Urine M\-protein level \=200 mg/24 h; or
•4\.3\. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \=10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
•4\.4\. For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion \=2 cm (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET\-CT) Scans (or whole body magnetic resonance imaging \[MRI] approved by sponsor), and not previously radiated

Exclusion Criteria

•Current exclusion criteria as of 02/01/2024:
•For participants with relapsed or refractory multiple myeloma:
•1\. Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required.
•2\. Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M\-protein, and skin changes), or primary light chain amyloidosis
•3\. Received a cumulative dose of corticosteroids equivalent to \>140 mg of prednisone within the 14\-day period before the start of study treatment administration
•4\. Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor \[PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene\-modified adoptive cell therapy or CD\-3 redirecting therapy within 90 days)
•5\. Prior allogeneic transplant within 6 months or autologous transplant within 12 weeks
•6\. Live, attenuated vaccine within 4 weeks before the first dose of study treatment
•7\. Non\-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade \=1 (except alopecia, tissue post\-RT fibrosis \[any grade] or peripheral neuropathy to Grade \=3\)
•8\. The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to the first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction \=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, etc)