A one-page dose-finding strategy for a T-cell engager
Which dose decisions are open, when each is due, and whether the team agrees
A T-cell engager (TCE) program owes around twenty dose and regimen decisions between the first-in-human protocol and the label. They are made at different times by different functions, and no single document holds the list, so a decision taken as provisional in year one is found in year four to have committed the program.
This project builds one landscape page that holds the list. For each decision: where it stands, when it is due, what evidence will answer it, whether the team agrees, and who decides. The page is revisited at each milestone rather than written once.
The starting point is the dose and regimen framework Sander et al. published in 2021, which runs to two pages and is written for any drug. This narrows it to one page and to the decisions a TCE actually faces, the step-up schedule first.
Nothing here has been used on a program, and the source paper has not been read in full.
Documents
- Working specification. What the page holds, the seven columns and why each earns its width, the two status axes, the TCE decision inventory, the gates, and the departures from the initial notes with a reason for each. Its In brief section is one screen and says what the rest argues.
- Specimen page. The artifact itself, filled in for an invented program, with the blank template underneath it to copy.
- References. What to read and in what order, and a marker on every source recording whether the claim drawn from it has been checked. Every marker is currently ❌.