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Varnimcabtagene autoleucel (IMN-003A), frequently referred to by its clinical trial name **BROAD-CAR**, is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy. Developed by Immuneel Therapeutics in collaboration with the University of Pennsylvania and the Children's Hospital of Philadelphia (CHOP), it is designed to treat relapsed or refractory B-cell malignancies, including B-cell acute lymphoblastic leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL). The therapy utilizes a CAR construct featuring an anti-CD19 scFv (FMC63) linked to a 4-1BB (CD137) costimulatory domain and a CD3-zeta signaling domain. This specific construct is identical to the one used in tisagenlecleucel, which Immuneel licensed for development and manufacturing in India. The treatment involves genetically modifying a patient's own T cells to express the CAR, which then enables them to recognize and eliminate CD19-positive malignant B cells upon re-infusion. It is notable for being the first CAR-T cell therapy to undergo extensive clinical development and local manufacturing within India.
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