Severe disease, strict endpoints in CAR T trials ‘could be a way through the regulators’

SAN DIEGO — Regulatory trials of chimeric antigen receptor T-cell therapies for autoimmune diseases could be successful with a focus on patients with severe disease and strict endpoints, according to a speaker.
After reviewing his team’s recent successes in using CAR T-cell therapies for autoimmune diseases at the 2024 Congress of Clinical Rheumatology West, Georg Schett, MD, vice president of research and head of internal medicine at Friedrich-Alexander University Erlangen-Nürnberg, in Germany, was asked for his views on potential regulatory paths forward.
While noting

SAN DIEGO — Regulatory trials of chimeric antigen receptor T-cell therapies for autoimmune diseases could be successful with a focus on patients with severe disease and strict endpoints, according to a speaker.
After reviewing his team’s recent successes in using CAR T-cell therapies for autoimmune diseases at the 2024 Congress of Clinical Rheumatology West, Georg Schett, MD, vice president of research and head of internal medicine at Friedrich-Alexander University Erlangen-Nürnberg, in Germany, was asked for his views on potential regulatory paths forward.
While noting