A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64052781, a Humanized CD19 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Subjects with Relapsed or Refractory B-cell Malignancies
The purpose of this study is to find the highest dose of the investigational drug JNJ-64052781 that can be given safely to patients with mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), or chronic lymphocytic leukemia (CLL) that has come back or continued to grow despite other therapy.
JNJ-64052781 works by targeting two different proteins. One is CD19 and is found on some lymphoma cells and CLL cells. The other is CD3, which is found on white blood cells called T cells. JNJ-64052781 is designed to provoke an immune response by T cells to find and kill cancer cells that contain CD19. JNJ-64052781 is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have mantle cell lymphoma, follicular lymphoma, CLL, or DLBCL that has continued to grow or has come back despite treatment.
- Patients may not have had prior treatment that targeted CD3 or CD19.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.