March Biosciences’ T-cell Lymphoma Therapy Reaches Milestone
The first patient has been dosed in a Phase II clinical trial for the company’s MB-105 first-in-class CD5-targeted CAR-T cell therapy.
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March Biosciences, a clinical-stage biotechnology company, announced on April 22, 2025 that the first patient has been dosed in its Phase II clinical trial evaluating the company’s first-in-class CD5-targeted chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma, MB-105.
MB-105, designated as an orphan-drug, is an autologous CD5-targeted CAR-T cell therapy that treats CD5-positive hematologic malignancies, including T-cell lymphoma, T-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, and mantle cell lymphoma.Its proprietary CAR design enables selective targeting of malignant cells while preserving normal T-cell function.
A Phase II multi-center, single-arm, two-stage, open-label study is evaluating the safety and efficacy of MB-105 in patients with relapsed or refractory CD5-positive T-cell lymphoma. The trial will be conducted at cancer centers across the United States and is led by Swaminathan P. Iyer, MD, professor in the Department of Lymphoma/Myeloma at MD Anderson. Approximately 46 patients will be enrolled across both stages.
“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” said Sarah Hein, co-founder and chief executive officer of March Biosciences, in a press release (1). “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.”
In October 2024, the company acquired Series A financing led by Mission BioCapital and 4BIO Capital, with participation from KdT Ventures, Alexandria Venture Investments, Volnay Therapeutics, Modi Ventures, and Mansueto Investments. FDA orphan drug designation was given for MB-105 in January 2025. This designation includes development incentives and seven years of market exclusivity following potential FDA approval.
In March 2025, Hein spoke to BioPharm International® about the types of diseases MB-105 targets (2). “The majority of those diseases are derived from your B cells. And there's a lot of therapies available for those patients all the way up to and including these very powerful cell therapies,” Hein said. “Unfortunately, for the T cell malignancies, what we see is there really is no standard of care for these patients after the disease becomes relapsed or refractory to primary care, and so, unfortunately, the prognosis is very, very poor, and there's a number of challenges that have held back the development of cell therapies for these diseases.”
Hein also spoke about what she considers an exciting time for oncology drug development, including novel therapies and retargeting classic modalities. “But where I've really been excited, both for this company and my prior company, is really around the emergence and impact of immunotherapies. Immunotherapies allow you to retarget the immune system itself and harness the power of the immune system to directly fight the cancer within the body,” Hein said. “And for the first time, you are seeing curative, potentially, responses a large number of patients who are achieving long-term, durable remissions. Some of these are usually just uninhibiting the immune system, but where we've really been leaning into is the cell therapies, where you can engineer and turbocharge those cells directly to target a cancer.”
References
- March Biosciences. March Biosciences Doses First Patient in Phase 2 Trial of CAR-T Therapy for Rare Blood Cancer. Press Release. April 22, 2025.
- Haigney, S. Novel Oncology Biotherapeutics: CAR-T Cell Therapy. BioPharmInternational.com. March 27, 2025. https://www.biopharminternational.com/view/novel-oncology-biotherapeutics-car-t-cell-therapy
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