March Biosciences Reports 100% Complete Response Rate with MB-105 CAR-T Therapy in Relapsed T-Cell Lymphoma
核心洞察
March Biosciences (搜索) achieved a 100% complete response rate in five evaluable patients with relapsed/refractory T-cell lymphoma (搜索) using its CD5 (搜索)-targeted CAR-T therapy MB-105.
The therapy demonstrated robust CAR-T cell expansion with 75% of total CD3 (搜索)+ T cells at day 14, persisting beyond day 28, along with an acceptable safety profile.
The Independent Data Monitoring Committee approved advancement to Simon Stage 2 of the Phase 2 trial, with updated results expected at medical conferences in 2026.
March Biosciences (搜索) announced positive interim clinical data from its ongoing Phase 2 trial of MB-105, a CD5 (搜索)-targeted CAR-T cell therapy, at the 67th American Society of Hematology Annual Meeting in Orlando, Florida. The company reported a 100% complete response rate in the primary efficacy cohort of heavily pretreated patients with relapsed/refractory T-cell lymphoma (搜索).
Breakthrough Efficacy Results
The interim data from the safety run-in cohort of six patients demonstrated remarkable clinical outcomes. All five evaluable patients in the primary cohort, defined as those with ≥50% CD5 (搜索) expression, achieved complete responses. These patients had previously undergone extensive treatment, having received between 2 to 8 different systemic cancer therapy regimens before enrolling in the MB-105 trial.
"What we're seeing with MB-105 is truly remarkable for this patient population," said Dr. Swami Iyer, Professor at The University of Texas MD Anderson Cancer Center and Principal Investigator of the study. "These patients had exhausted multiple treatment options, yet we achieved responses in every evaluable patient with manageable side effects."
Robust CAR-T Cell Performance
The therapy demonstrated exceptional CAR-T cell expansion and persistence. Following infusion, MB-105 showed robust expansion with a mean of 75% of total CD3 (搜索)+ T cells at day 14, with persistence extending beyond day 28. Early evidence suggested complete clearance of CD5 (搜索)-positive disease in most patients treated.
The safety profile remained acceptable and consistent with CAR-T therapy expectations and prior Phase 1 experience. This favorable tolerability profile, combined with the unprecedented efficacy results, represents a significant advancement for patients with limited treatment options.
Regulatory Recognition and Trial Advancement
MB-105 has received both Regenerative Medicine Advanced Therapy Designation (RMAT) and Orphan Drug Designation from the FDA for treating relapsed/refractory CD5 (搜索)-positive T-cell lymphoma (搜索). The Independent Data Monitoring Committee has approved advancement to Simon Stage 2 of the Phase 2 trial, allowing continued enrollment.
"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 (搜索)," said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences (搜索). "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."
First-in-Class Therapeutic Approach
MB-105 represents a potential first-in-class autologous CD5 (搜索)-targeted CAR-T cell therapy in development for CD5-positive hematologic malignancies. Beyond T-cell lymphoma (搜索), the therapy is being developed for T-cell acute lymphoblastic leukemia (搜索) (T-ALL), chronic lymphocytic leukemia (搜索) (CLL), and mantle cell lymphoma (搜索) (MCL). The therapy employs a proprietary CAR design that enables selective targeting of malignant cells without additional genetic manipulation.
March Biosciences (搜索), launched from the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital, and Texas Children's Hospital, has raised over $53 million to date through venture financing, support from the Cancer Prevention & Research Institute of Texas (CPRIT), and the NIH SBIR program.
The company anticipates presenting updated clinical and correlative results at upcoming medical conferences in 2026, as the Phase 2 clinical trial (NCT06534060) continues enrolling patients with relapsed/refractory T-cell lymphoma (搜索).