The FDA clears an Investigational New Drug application for CAP-100

On February 8, 2021, it was announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application for CAP-100, a first-in-class humanized anti-C-C chemokine receptor 7 (CCR7) antibody, for the treatment of hematological malignancies. This clearance allows for the initiation of a phase I trial (NCT04704323) in patients with relapsed/refractory chronic lymphocytic leukemia.¹

CAP-100^1,2

• A first-in-class humanized monoclonal antibody that specifically binds to CCR7.
  • CCR7 is essential for the migration of immune cells to the lymphoid organs and is overexpressed in hematological malignancies with lymph node involvement.
  • Preclinical studies demonstrated that the Fc-mediated antibody-dependent cell-mediated cytotoxicity of CAP-100 was better than that of rituximab.

NCT04704323^1,3

• An open label, phase Ia/b dose escalation/dose expansion study to assess the safety and tolerability of CAP-100 monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia, who have received ≥ 2 prior lines of therapy.
• Dose escalation phase will be used to define the recommended phase II dose.
• Does expansion phase will investigate the safety and preliminary clinical benefit of CAP-100 at the recommended phase II dose.
• Estimated enrollment number: 25.
• Estimated start date: March 2021.