March Biosciences to Present Interim Phase 2 Data for First-in-Class CD5-Targeted CAR-T Therapy at ASH 2025
核心洞察
March Biosciences (搜索) will present interim Phase 2 clinical data for MB-105, a first-in-class autologous CD5 (搜索)-targeted CAR-T cell therapy, at the American Society of Hematology Annual Meeting in December 2025.
MB-105 employs a proprietary CAR design that enables selective targeting of malignant cells without additional genetic manipulation and has received FDA orphan drug designation for relapsed/refractory CD5 (搜索)-positive T-cell lymphoma (搜索).
The therapy is designed to minimize T-cell fratricide while targeting CD5 (搜索)-positive hematologic malignancies including T-cell lymphoma (搜索), T-ALL, chronic lymphocytic leukemia (搜索), and mantle cell lymphoma (搜索).
March Biosciences (搜索) announced that interim clinical data from its ongoing Phase 2 trial of MB-105 will be presented at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, scheduled for December 6-9, 2025, in Orlando, Florida. The Houston-based clinical-stage biotechnology company is developing MB-105 as a first-in-class autologous CD5 (搜索)-targeted CAR-T cell therapy for patients with relapsed/refractory T-cell lymphoma (搜索) and other CD5-positive hematologic malignancies.
Novel CAR Design Addresses T-Cell Fratricide Challenge
MB-105 employs a proprietary CAR design that enables selective targeting of malignant cells without additional genetic manipulation. The novel CAR design is expected to minimize T-cell fratricide, ensuring more precise targeting of malignant cells. This approach represents a significant advancement in addressing one of the key challenges in developing CAR-T therapies for T-cell malignancies, where the therapy targets the same antigen present on both malignant and therapeutic T-cells.
The therapy has received Orphan Drug Designation from the FDA for the treatment of relapsed/refractory CD5 (搜索)-positive T-cell lymphoma (搜索), recognizing the significant unmet medical need in this patient population.
ASH Presentation Details
The interim analysis will be presented by Professor Swami Iyer from MD Anderson Cancer Center during an oral presentation titled "Interim analysis of safety and efficacy in a Phase 2 study of MB-105, a CD5 (搜索).CAR T therapy for patients with relapsed/refractory T cell lymphoma." The presentation is scheduled for December 8, 2025, from 10:30 to 10:45 AM ET in the Tangerine Ballroom F1, as part of the session on novel agents or therapeutic approaches in T-cell lymphoma (搜索).
Broad Therapeutic Potential
MB-105 is being developed for multiple CD5 (搜索)-positive hematologic malignancies, including T-cell lymphoma (搜索) (TCL), T-cell acute lymphoblastic leukemia (搜索) (T-ALL), chronic lymphocytic leukemia (搜索) (CLL), and mantle cell lymphoma (搜索) (MCL). The Phase 2 clinical trial of MB-105 (NCT06534060) is currently enrolling patients with relapsed/refractory T-cell lymphoma.
Company Background and Funding
March Biosciences (搜索) was launched from the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital, and Texas Children's Hospital. The company is dedicated to addressing challenging cancers unresponsive to current immunotherapies. March Biosciences has raised over $53 million to date, including venture financing, support from the Cancer Prevention & Research Institute of Texas (CPRIT), and the NIH SBIR program.