Initial Look at CLN-978 Data Ahead of EULAR

研报英文原文证据摘录

Initial Look at CLN-978 Data Ahead of EULAR

Quick Note

May 19, 2026 Cullinan Therapeutics (CGEM)

Rating: Initial Look at CLN-978 Data Ahead of EULAROUTPERFORM

Price:

$14.87 CGEM reported initial details on upcoming CLN-978 data to be presented

12-Month Price Target: at EULAR 2026 (link, here), detailing initial data from the OUTRACE-RA and

$37.00 OUTRACE-SLE Ph 1 trials. As of a January 2026 data cutoff, 14 patients had been

dosed across the RA (n=5) and SLE (n=9) trials, with all Day 1 step-up doses at 10

µg and target doses of 20 µg (cohort 2) or 30 µg (cohort 3). Notably, early clinical

Analysts signals were encouraging, with 4 of 5 RA patients showing decreases in DAS28-ESR

Robert Driscoll, Ph.D. and 5 of 6 SLE patients showing a ≥4-point reduction in SLEDAI score among those

(415) 274-6863 with at least 4 weeks of follow-up. Further, B cell depletion was robust — followingRobert.Driscoll@wedbush.com

10 µg dosing, 9/11 patients exhibited >75% B cell depletion relative to baseline,Geoffrey Von Der Ahe

(628) 223-0517 and following 20 µg dosing, 3/6 patients achieved depletion below the level of

geoffrey.vonderahe@wedbush.com quantification; this included an instance of complete clearance of CD19+ B cells in

both peripheral blood and synovial tissue in an RA patient in cohort 2. Regarding

tolerability, CRS occurred in 4 patients; all instances were limited to Grade 1 and

occurred only following the 10 µg step-up dose. No CRS was reported after any

target dose administration, and no cases of ICANS were reported, consistent with

the favorable tolerability profile observed preclinically. As a reminder, the OUTRACE

studies enrolled a single dose cohort (10 µg, Cohort 1), a two cohorts evaluating

two doses with step up – Day 1: 10 µg, Day 8: 20 µg; Cohort 2 and Day 1: 10