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A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma

Protocol No
JANSSEN-64407564MMY1002
Principal Investigator
Parameswaran Hari
Phase
I
Summary
JNJ-64407564 [anti-GPRC5DxCD3] is called a bispecific antibody because it has two arms that target a protein on the myeloma cells, GPRC5D, and a protein on T-cells, CD3. T-cells are a type of cell that can kill cancer cells. JNJ-64407564 [anti-GPRC5DxCD3] brings these killer T-cells to the myeloma cell resulting in myeloma cell death. JNJ-64007957 [anti-BCMAxCD3] is called a bispecific antibody because it has two arms that target a protein on the myeloma cells, BCMA, and a protein on T-cells, CD3. T-cells are a type of cell that can kill cancer cells. JNJ-64007957 [anti-BCMAxCD3] brings these killer T-cells to the myeloma cell resulting in myeloma cell death. Daratumumab is a human monoclonal antibody or protein drug. An antibody is something that finds and kills foreign cells and organisms in your body, in this case, myeloma cells.
Description
The purpose of this study is to find a safe and tolerable dose of either JNJ-64407564 [anti-GPRC5DxCD3] or JNJ-64007957 [anti-BCMAxCD3] when administered in combination with Daratumumab subcutaneous injection (Dara SC) in patients with multiple myeloma. A dose is how much of a drug you take at one time. This study will also look at how JNJ-64407564 [anti-GPRC5DxCD3] and Dara SC, known as combination 1 or JNJ-64007957 [anti-BCMAxCD3] and Dara SC, known as combination 2 act in your body, as well as whether each of the combination of drugs will treat your multiple myeloma.

1. Combination 1: JNJ-64407564 [anti-GPRC5DxCD3] and Dara SC
2. Combination 2: JNJ-64007957 [anti-BCMAxCD3] and Dara SC

Another purpose of this study is to find out how long JNJ-64407564 [anti-GPRC5DxCD3] or JNJ-64007957 [anti-BCMAxCD3] in combination with Dara SC stay in and act on your body. This is measured by blood tests.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL