Zynteglo: how was the first human dose set?

The public FDA and EMA reviews of Zynteglo don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

FDA expects preclinical proof-of-concept and toxicology studies to identify active dose levels and support the choice of starting dose and escalation. The 2013 guidance gives no numeric formula or scaling rule for the starting dose.

NOAEL / key findings: No NOAEL defined; no test-article-related mortality or adverse effects at 42x10^6 cells/kg; lymphomas judged incidental (radiation/strain background) (FDA pharmacology/toxicology review, p. 12)

Full method, every step sourced →