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A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

2019-10-03 07:54:42 | BioPortfolio

Summary

The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) and schedules for each combination (combination 1: daratumumab and JNJ-64407564 [anti-GPRC5DxCD3] or combination 2: daratumumab and JNJ-64007957 [anti-BCMAxCD3]) and to characterize the safety of each RP2D for each combination.

Description

Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure. Overall rationale of study is that daratumumab in combination with JNJ-64407564 [anti-GPRC5DxCD3] or JNJ-64007957 [anti-BCMAxCD3] may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Daratumumab is human immunoglobulin G1 kappa monoclonal antibody (IgG1k) that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38) in a variety of hematological malignancies including multiple myeloma. JNJ-64407564 (anti-GPRC5DxCD3) and JNJ-64007957 (anti-BCMAxCD3) are bispecific T cell redirection antibodies. JNJ-64407564 (anti-GPRC5DxCD3) binds to cluster of differentiation 3 (CD3) receptor complex on T cells and to G protein-coupled receptor family C group 5-member D (GPRC5D), a 7‑transmembrane receptor protein on plasma cells and JNJ-64007957 (anti-BCMAxCD3) binds to human and cynomolgus-CD3 and B cell maturation antigen (BCMA). Purpose of study is to evaluate safety of daratumumab in combination with bispecific T cell redirecting antibodies, and to evaluate antitumor activity of each combination. Study consists of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up period (after end of treatment and up to 16 weeks after last dose. End of study is defined as last study assessment for last participant in study. Total duration of study is approximately 2.4 years. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Participants safety will be monitored throughout study by Study Evaluation Team (SET). SET consists of members of sponsor's study team and participating investigators.

Study Design

Conditions

Multiple Myeloma

Intervention

Daratumumab, JNJ-64407564, JNJ-64007957

Location

City of Hope National Medical Center
Duarte
California
United States
91010

Status

Not yet recruiting

Source

Janssen Research & Development, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-03T07:54:42-0400

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Medical and Biotech [MESH] Definitions

An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

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