The FDA expects early-phase CAR T-cell therapy trials to focus primarily on the risks of toxicity, according to a new draft guidance that also addresses manufacturing and preclinical considerations in developing CAR T-cell therapies.

In addition to monitoring and treating participants for an overreactive immune response, including high levels of cytokine release, the guidance recommends that first-in-human trials and trials of products that have had limited experience in humans consider using staggered enrollment in order to minimize exposure to unacceptable toxicities.

The guidance also urges sponsors to establish limits for increasing dosage, recommending criteria for high levels of cytokine release, allergic reactions to cell infusion, organ toxicity and autoimmune toxicity.

The FDA will accept comments on the draft at any time.

Read the full guidance here: https://bit.ly/3MXHvcd.