Novartis paused and is investigating multiple clinical trial programs for rapcabtagene autoleucel after three patient fatalities tied to severe autoimmune reactions. The events were associated with immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), a known serious complication risk in CAR-T contexts. Bristol Myers Squibb followed by implementing a voluntary pause in its zola-cel autoimmune trials after reports of inflammatory events in study patients. Both companies cited safety review needs and signaled intent to resume enrollment once data are evaluated. The actions highlight ongoing scrutiny of benefit-risk thresholds and risk mitigation in autoimmune CAR-T settings, where immune activation can manifest as life-threatening inflammatory toxicities.