MB-CART 2219.1 / Miltenyi Biotec - LARVOL DELTA

Multiomic signatures of durable response in a Phase I/II trial of tandem aCD22-aCD19 CAR-T therapy for relapsed B-lineage acute lymphoblastic leukaemia (ASH 2025) - "We conducted a phase I/II trial of the dual aCD22-aCD19 CAR-Ttherapy (MB-CART2219.1) for adults and children with relapsed/refractory B-lineage acute lymphoblasticleukemia across three tertiary insitutions. Tandem aCD22-aCD19 CAR-T (CART2219.1) as a stand-alone infusion in relapsed/refractoryB-ALL is promising, with a median overall survival and LFS not reached at 24 months. Multiomic analysisof product and post-infusion signatures highlight effector functionality at infusion and memory transitionpost-infusion as key determinants of long-term CAR-T efficacy."

IO biomarker • P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • CD8 • ENTPD1 • GZMB • HAVCR2 • IFNG • IL7R • LAG3 • PD-1 • TIGIT • TNFSF10

A Phase I Dose Finding Study of MB-CART2219.1 (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: University Hospital Tuebingen

New P1 trial • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Pediatrics

Manufacturing Characteristics and Early Outcomes of a Tandem aCD22-aCD19 CAR-T Therapy for Childhood and Adult Relapsed/Refractory Acute Precursor B Lymphoblastic Leukemia (TCT-ASTCT-CIBMTR 2025) - "Patients received fludarabine and cyclophosphamide lymphodepletion followed by a single fresh infusion of MB-CART2219.1 manufactured in a 12-day vein-to-vein protocol. MB-CART2219.1 is a promising definitive treatment for multiply relapsed or primary refractory (high MRD) B-ALL. An ongoing Phase II study will confirm the early efficacy and safety results. Multiomic analysis in a representative subset of patients suggests that cytotoxic effector potential of CAR-T is important for long-term response."

Clinical • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD22 • CD27 • CD4 • CD8 • GZMB • IFNG • IL7R • NCAM1 • TNFSF10