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The FDA granted RMAT designation to MB-105 for CD5-positive relapsed/refractory T-cell lymphoma.
The FDA has granted regenerative medicine advanced therapy (RMAT) designation to the investigational CD5-targeted autologous CAR T-cell therapy MB-105 for the treatment of patients with CD5-positive relapsed/refractory T-cell lymphoma.1
The designation was based on data from an ongoing phase 2 trial (NCT06534060), which is evaluating MB-105 in patients with CD5-positive T-cell lymphoma.1,2
Preliminary data from the trial’s safety run-in cohort showed that the CAR T-cell therapy displayed signals of clinical activity and was associated with a manageable safety profile.1 Full data from this cohort will be presented at the 2025 ASH Annual Meeting in December, and additional updates are expected in 2026.
“The FDA’s RMAT designation further validates MB-105’s potential to address a critical unmet medical need for patients with relapsed/refractory T-cell lymphoma, who face a median survival of only six months with current therapies,” Sarah Hein, co-founder and chief executive officer of March Biosciences, stated in a news release. “We are encouraged by the responses observed to date and look forward to working closely with the FDA to advance MB-105 as efficiently as possible.”
The open-label, multicenter, single-arm, 2-stage trial is enrolling patients at least 18 years of age with relapsed/refractory T-cell lymphoma, including patients with relapsed/refractory cutaneous T-cell lymphoma who have progressed on at least 2 prior lines of standard-of-care (SOC) therapy and those with relapsed/refractory peripheral T-cell lymphoma who have progressed on at least 1 prior line of SOC therapy.2 Prior treatment with brentuximab vedotin (Adcetris) is required for patients with CD30-positive T-cell lymphoma. CD5-positive disease per local testing is also required, which is defined as a CD5 expression of at least 50%. Prior CAR T-cell therapy is permitted if treatment occurred more than 60 days prior to enrollment, and patients cannot have evidence of CAR persistence. Patients also must be more than 60 days removed from prior autologous or allogenic hematopoietic stem cell transplant.
Other key inclusion criteria comprise a Karnofsky performance score of at least 70%; measurable or detectable disease; and adequate bone marrow and organ function.
Investigators are excluding patients who received any prior CD5-targeted therapy. Key exclusion criteria comprise Sezary syndrome; contraindication to leukapheresis; active HIV, chronic hepatitis B, or hepatitis C; active central nervous system lymphoma; and evidence of grade 3 or higher acute graft vs host disease (GVHD) or chronic GVHD requiring ongoing systemic steroids and/or multiagent therapy.
All patients are receiving MB-105. The first stage of the study included approximately 15 patients, and it featured an independent data monitoring committee review of safety data after the first 6 patients were treated with MB-105 at the recommended phase 2 dose and were followed for at least 30 days. After the safety review, enrollment in stage 1 was completed. Stage 2 would allow for the continued exploration of the RP2D in approximately 31 additional patients; enrollment for the second stage was permitted after a review of efficacy and safety data from the first stage.
Safety and overall response rate are serving as the trial’s primary end points. Secondary end points include duration of response, progression-free survival, overall survival, and additional safety objectives.
Enrollment in the study is ongoing at 12 centers in the United States.1
In January 2025, the FDA also granted orphan drug designation to MB-105 for the treatment of patients with relapsed/refractory CD5-positive T-cell lymphoma.3
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