Allogeneic CD7-targeted CAR-T for T1D: review notes

Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.

Registry: NCT07528105. Registered endpoint checked: Safety: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) in participants with type 1 diabetes mellitus treated with RD13-02. (From the date of signing informed consent to 3 months after CAR-T cell infusion.); Change from baseline in 4-hour MMTT C-peptide AUC at Months 3, 6, and 12. (From baseline to Month 12.). Eligibility check: Registry age 18 Years to 40 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.