<h1>Domestic CAR-T therapy used in adult relapsed Pre-B ALL: safe infusion, manageable AEs, raises regulatory and liability questions</h1> A tertiary hospital in Eastern India administered domestically manufactured CAR-T cell therapy to a 31-year-old adult with high-risk relapsed Pre-B acute lymphoblastic leukemia after standard chemotherapy failed, reporting a smooth infusion, manageable febrile and fatigue-related adverse events and no neurotoxicity. Legally relevant points include use of an India-made cellular product under institutional clinical protocols, preconditioning chemotherapy, documentation of informed consent and adverse-event monitoring, and potential regulatory, product-liability and standard-of-care implications as CAR-T expands in domestic clinical practice and access to advanced therapies increases.