Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom

Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors.

In‑vivo CAR‑T aims to generate engineered T cells directly inside a patient, unlike the current ex‑vivo approach that requires harvesting, modifying, expanding and reinfusing cells. The new method could shorten the time to infusion, lower manufacturing costs and expand access to many more patients.

Major pharmaceutical companies including Eli Lilly, AbbVie and AstraZeneca have announced programs to develop in‑vivo CAR‑T, signaling strong industry interest. However, safety concerns remain prominent, and the broader challenges of cell‑therapy manufacturing and pricing persist.

The technology still requires extensive clinical and regulatory validation before it can be considered a viable commercial option.