A Phase 2, Open-label, Multicenter Study of MB-105 in Patients With CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL).
March Biosciences Inc
Summary
This is a single arm, two-stage, Phase 2, open-label, multicenter study of MB-105 in patients with CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL). This study will apply a Simon two-stage optimal design.
Description
The first stage of the Simon two-stage design will enroll approximately 15 evaluable patients. Once the first 6 patients are enrolled, have received one dose of MB-105 at the recommended phase 2 dose (RP2D), and completed at least up to Day 30 of the study, the Independent Data Monitoring Committee (IDMC) will perform a safety analysis. The IDMC will use this analysis to confirm that the RP2D selected for this Phase 2 study is the appropriate dose of MB-105 for further clinical evaluation. The IDMC will either recommend continuing the remainder of the study at the fixed dose of 50 million (5 x…