Phase 1 Study of CC312 for Adults With Relapsed or Refractory CD19 Positive B-cell Blood Cancers

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics PK, pharmacodynamics PD, and immune response to CC312, a biological therapy given by intravenous infusion, in adults with relapsed or refractory CD19-positive B-cell hematologic cancers including non-Hodgkin lymphoma and B-cell lymphocytic leukemia. This Phase 1 open-label study aims to find the best dose levels and understand how the drug behaves in the body and its potential anti-tumor effects. The study has two parts. Part 1 uses an accelerated dose-escalation design where patients receive escalating doses of CC312 through a priming dose, an intermediate dose, and then twice-weekly doses for three weeks. Part 2-A continues dose escalation with more patients to confirm the maximum tolerated dose or recommended Phase 2 dose, followed by Part 2-B where additional patients receive treatment at these doses. The doses range from 0.3 to 45 micrograms given intravenously. Participants will have scheduled visits including blood tests to measure drug levels, immune markers, and side effects during treatment cycles lasting 28 days. Researchers will carefully monitor for dose-limiting toxicities and adverse events up to 28 days after treatment. The study includes assessments before and during treatment to understand the bodys response and safety profile. Total participation length depends on individual treatment and follow-up schedules.

Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies