March Biosciences has dosed the first patient in a Phase 2 clinical trial for MB-105, a CD5-targeted CAR-T cell therapy designed for relapsed or refractory CD5-positive T-cell lymphoma. The trial will assess the safety and efficacy of MB-105 in approximately 46 patients across multiple U.S. centers. This builds on promising Phase 1 results showing a favorable safety profile and durable remissions in heavily pretreated patients.
This advancement is particularly important because T-cell lymphomas represent a significant unmet medical need with limited treatment options. While CAR-T therapies have proven successful against B-cell malignancies, they haven’t effectively translated to T-cell lymphomas. MB-105’s novel CAR design offers the potential to selectively target malignant T-cells while sparing healthy ones, a crucial factor for improving treatment outcomes and minimizing side effects.
The Phase 2 trial is a multi-center, open-label study. Phase 1 results showed a 93% manufacturing success rate for CD5 CAR-T cells and no high-grade cytokine release syndrome or neurological events, suggesting a manageable safety profile. This progress follows a successful Series A funding round in late 2024, which facilitated the rapid achievement of key clinical and regulatory milestones, including FDA orphan drug designation for MB-105 in early 2025.
The initiation of this Phase 2 trial represents a critical step towards potentially providing a much-needed therapy for patients with T-cell lymphoma. Positive results could significantly alter the treatment landscape for these patients and pave the way for further development of targeted CAR-T therapies for other challenging hematological malignancies. The data from this trial will be crucial in determining the future trajectory of MB-105 and its potential to address this critical unmet need.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
