The FDA signaled a willingness to adopt a flexible, risk‑proportionate regulatory approach for CAR‑T therapies targeting autoimmune disorders, indicating developers should prepare long‑term safety monitoring plans, especially for oncogenic or fertility risks. Agency comments suggest regulators will “carefully shepherd” these programs rather than blocking development outright. The guidance sets the tone for sponsors planning first‑in‑human autoimmune CAR‑T trials: expect emphasis on patient selection, durability endpoints, and multi‑year follow‑up. The agency’s stance could accelerate investment and IND activity in cell therapies for autoimmunity while establishing new post‑approval safety frameworks.