March Biosciences Presents Positive Interim Clinical Data from Phase 2 Trial of MB-105 CD5 CAR-T Cell Therapy at ASH 2025 Annual Meeting
100% complete response rate achieved in primary cohort with acceptable safety profile in relapsed/refractory T-cell lymphoma patients
HOUSTON, Dec. 08, 2025 (GLOBE NEWSWIRE) -- March Biosciences (March Bio), an clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced positive interim clinical data from its ongoing Phase 2 trial of MB-105 at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, being held December 6-9, 2025, in Orlando, Florida.
The interim data, being featured in an oral presentation titled “Interim analysis of safety and efficacy in a Phase 2 study of MB-105, a CD5.CAR T therapy for patients with relapsed/refractory T cell lymphoma,” is from the safety run-in cohort of six patients. Prior to receiving MB-105 in the trial, these patients had been heavily treated with 2 to 8 different systemic cancer therapy regimens. The data demonstrated promising efficacy with a 100% complete response rate in primary efficacy cohort patients (≥ 50% CD5 expression), accompanied by a favorable safety profile.
Key Highlights from ASH 2025 Oral Presentation:
- 100% complete response rate (5 of 5 evaluable patients in primary cohort)
- Robust CAR-T expansion following infusion with mean 75% of total CD3+ T cells at day 14, persisting beyond day 28
- Early evidence suggesting complete clearance of CD5-positive disease in most patients treated
- Acceptable safety profile consistent with CAR-T therapy expectations and prior Phase 1 experience
“These data represent an important milestone for March Bio and underscore the potential of MB-105 to address the significant unmet medical need in T-cell lymphoma,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “The 100% complete response rate we’ve observed in the evaluable primary cohort, along with the favorable safety profile and robust CAR-T expansion, gives us tremendous confidence as we advance this potentially transformative therapy.”
Dr. Swami Iyer, Professor at The University of Texas MD Anderson Cancer Center and Principal Investigator of the study, said, “What we’re seeing with MB-105 is truly remarkable for this patient population. These patients had exhausted multiple treatment options, yet we achieved responses in every evaluable patient with manageable side effects. The robust CAR-T cell expansion and persistence we observed suggest this approach could fundamentally change how we treat relapsed and refractory T-cell lymphomas.”
March Bio is continuing enrollment in the Phase 2 trial, with the Independent Data Monitoring Committee’s approval to advance to Simon Stage 2 of the Phase 2 trial. The Company anticipates presenting updated clinical and correlative results at upcoming medical conferences in 2026.
About MB-105
MB-105 is a potential first-in-class autologous CD5-targeted CAR-T cell therapy in development for CD5-positive hematologic malignancies, including T-cell lymphoma (TCL), T-cell acute lymphoblastic leukemia (T-ALL), chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL). The therapy employs a proprietary CAR design that enables selective targeting of malignant cells without additional genetic manipulation. MB-105 has received the Regenerative Medicine Advanced Therapy Designation (RMAT) and Orphan Drug Designation from the FDA for the treatment of relapsed/refractory CD5-positive TCL. The Phase 2 clinical trial of MB-105 (NCT06534060) is currently enrolling for patients with relapsed/refractory T cell lymphoma.
About March Biosciences
Houston-based March Biosciences, launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children’s Hospital), is dedicated to addressing challenging cancers unresponsive to current immunotherapies. Its lead asset, MB-105, is a CD5-targeted CAR-T cell therapy currently in Phase 2 clinical development for patients with relapsed/refractory T-cell lymphoma. The company has raised over $53 million to date, inclusive of venture financing, support from the Cancer Prevention & Research Institute of Texas (CPRIT), and the NIH SBIR program. Learn more at www.march.bio.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Any statement describing March Biosciences’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in these forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the clinical development of MB-105, the progress of clinical trials for pipeline candidates, regulatory approvals, market demand for new therapies, competitive dynamics in the biotechnology sector, and macroeconomic conditions.
Contacts:
Corporate
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Josephine Galatioto
ICR Healthcare
MarchBioPR@icrhealthcare.com
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