March Biosciences Inc
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.
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…
Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Patients with r/r TCL per WHO 2022 criteria. 1. r/r CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy. 2. r/r PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin. 3. Has available tumor tissue or is willing to undergo a biopsy procedure. 4. CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT. CD5 positivity is currently defined as having ≥ 50% CD5 expression. An exploratory cohort will enroll patie…
MB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.