Sarah Hein, PhD, on the Phase 2 Trial for CD5-Directed CAR-T MB-105 in R/R T-Cell Lymphoma

“If you're familiar with this indication, unfortunately once patients enter the r/r setting, there really is not a standard of care. These patients have about a less-than-20% survival over about 3 years, and that's because there's a handful of salvage therapies available to these patients, but not a lot else.”

Patients with relapsed/refractory (r/r) T-cell lymphoma currently have few options. As such, the unmet need for new therapies for this indication is quite substantial. One potential candidate to fulfill this role is MB-105, an investigational CD5-directed chimeric antigen receptor T-cell (CAR-T) therapy currently being evaluated for the treatment of r/r CD5-positive T-cell lymphoma. The therapy, which was invented at Baylor College of Medicine and is being developed by March Biosciences, is being evaluated in an ongoing phase 1 clinical trial (NCT03081910) that was launched in 2017 and a phase 2 clinical trial (NCT06534060) that recently launched on February 15, 2025.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30 to June 3, in Chicago, Illinois, March Biosciences is giving a presentation on the design of the new phase 2 clinical trial. Ahead of the meeting, CGTLive® sat down with Sarah Hein, PhD, the chief executive officer and cofounder of March Biosciences, to learn more.

Hein pointed out that MB-105 targets CD5, a protein expressed in 70% to 80% of peripheral and cutaneous T-cell lymphoma cases, making it broadly applicable. She also noted that the trial, which began enrolling patients earlier this year, uses a Simon 2-stage design and is being conducted at 12 sites across the United States. March Biosciences announced its first patient dosed about a month ago.

Hein highlighted the urgent need for innovative therapies in this space and encouraged physicians to refer eligible patients. She stressed the importance of reaching patients quickly. She also spoke about how while manufacturing and scale-up remain challenges, the company has built infrastructure to support current and future development. Hein additionally emphasized openness to new clinical sites and partnerships.