Study of CAP-100, an Antibody Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Phase 1 Dose Escalation and Expansion to Assess Safety and Effects

What this Trial Is About

Researchers are investigating CAP-100, a humanized antibody targeting C-C-chemokine receptor 7 CCR7, in people with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. Current treatments include targeted therapies and immuno-chemotherapy, but new options are needed for patients who cannot use or do not respond to these treatments. CAP-100 is designed to stop leukemia cells from surviving in lymphoid areas and to eliminate CCR7-positive leukemia cells, potentially leading to clinical responses. The trial has two parts Phase Ia dose escalation and Phase Ib dose expansion. In Phase Ia, small groups of participants receive increasing intravenous doses of CAP-100 to determine the recommended dose for Phase II. In Phase Ib, additional participants receive CAP-100 at the recommended dose to evaluate safety and early signs of benefit, including response rate, lymph node size reduction, and minimal residual disease assessment. Participants will undergo safety monitoring for treatment-related side effects during and after dosing. Researchers will measure clinical responses over three cycles 84 days to assess preliminary benefits. The study involves regular assessments including blood tests and imaging to monitor disease status and side effects. The trial aims to establish the proper dose and gather initial safety and effectiveness data to guide future studies.

CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia