en.Wedoany.com Reported - Cullinan Therapeutics (Nasdaq: CGEM) announced that it will present preliminary clinical data from two ongoing Phase 1 studies of its CD19xCD3 T cell engager, CLN-978, at the 2026 European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology. The data will be presented in a poster session (Poster Number POS1179) on June 6 at 10:15 AM BST. Cullinan Therapeutics is a clinical-stage biopharmaceutical company focused on accelerating the development of first-in-class or best-in-class T cell engagers for autoimmune diseases and cancer.
Jeffrey Jones, M.D., M.B.A., Chief Medical Officer of Cullinan Therapeutics, stated that patients with refractory systemic lupus erythematosus (SLE) and refractory rheumatoid arthritis (RA) showed clinical benefit, including disease remission, following a single target dose of CLN-978. These preliminary Phase 1 data indicate that CLN-978 achieves deep and dose-dependent B cell depletion, reinforcing its potential as a disease-modifying therapy across multiple refractory autoimmune diseases. The emerging favorable safety profile and subcutaneous administration support its potential to deliver substantial clinical benefit to patients in a community outpatient setting. As the company advances studies with multi-dose regimens, it is focused on rapidly progressing CLN-978 through global clinical development.
Ricardo Grieshaber-Bouyer, M.D., Ph.D., M.B.A., Professor of Clinical Systems Immunology and Head of the Clinical Trial Unit at Friedrich-Alexander-Universität Erlangen-Nürnberg and Global Lead Investigator for OUTRACE RA, stated that the data generated from this program represent one of the most comprehensive and rigorous datasets generated to date across multiple indications and biomarkers, which will help inform subsequent clinical development and ultimately clinical practice. Many RA and SLE patients continue to have active disease even after exhausting multiple available therapies, representing a significant unmet need. A single target dose of CLN-978 not only rapidly depletes B cells in the peripheral blood but also significantly depletes CD19+ B cells in lymph nodes and synovial tissue. The encouraging safety profile and clear dose-dependent effects provide strong evidence for its potential mechanism of action.
This presentation is based on data from 29 patients evaluated as of May 15, 2026, across different dose cohorts in the OUTRACE SLE and RA clinical trials. In the OUTRACE SLE trial, patients were grouped by dose: Cohort 1 (10 µg on Day 1, safety n=3, pharmacodynamics n=3, efficacy n=3), Cohort 2 (10 µg on Day 1, 20 µg on Day 8, safety n=7, pharmacodynamics n=7, efficacy n=4), Cohort 3 (10 µg on Day 1, 30 µg on Day 8, safety n=7, pharmacodynamics n=6, efficacy n=6), Cohort 4 (10 µg on Day 1, 45 µg on Day 8, safety n=1, pharmacodynamics n=1, efficacy n=1). Total SLE patients were 18, with 17 evaluable for pharmacodynamics and 14 evaluable for efficacy. In the OUTRACE RA trial, Cohort 1 (10 µg on Day 1, safety n=1, pharmacodynamics n=1, efficacy n=1), Cohort 2 (10 µg on Day 1, 20 µg on Day 8, safety n=3, pharmacodynamics n=3, efficacy n=3), Cohort 3 (10 µg on Day 1, 30 µg on Day 8, safety n=3, pharmacodynamics n=3, efficacy n=3), Cohort 5 (10 µg on Day 1, 20 µg on Days 8/15/22, safety n=4). Total RA patients were 11, with 7 evaluable for pharmacodynamics and 7 evaluable for efficacy.
In the OUTRACE SLE trial, among patients receiving a single target dose, 10 of 14 patients (71%) with ≥4 weeks of follow-up had a ≥4-point reduction in hSLEDAI score, with 5 achieving DORIS remission. All disease activity laboratory markers (anti-dsDNA, UPCR, C3, and C4) improved in patients with clinically significant abnormalities at baseline. Peripheral B cell counts decreased by >80% from baseline in 14 of 17 patients (82%), with dose-dependent recovery; 7 of 14 patients (50%) treated with a target dose of ≥20 µg achieved peripheral B cell depletion below the lower limit of quantification.
In the OUTRACE RA trial, in this heavily pre-treated population, 6 of 7 patients (86%) had high baseline disease activity, 5 of 7 patients (71%) showed improvement in disease activity, and one patient receiving a single target dose of 30 µg achieved DAS28-ESR remission. CLN-978 reduced RA autoantibody levels but had no effect on protective vaccine titers. Peripheral blood B cell depletion below the lower limit of quantification was achieved in 4 of 6 patients (67%) treated with a target dose of ≥20 µg. Dose-dependent B cell depletion was also observed in lymph nodes and synovial tissue.
Regarding safety, CLN-978 was well tolerated in the 10 µg, 20 µg, and 30 µg target dose cohorts, including in patients receiving three 20 µg target doses in a multi-dose regimen. Most cytokine release syndrome events were Grade 1 and occurred after the first dose (10 µg). One Grade 3 cytokine release syndrome event was observed following a 45 µg target dose; enrollment in this cohort has been stopped, and additional step-up doses may be implemented in subsequent multi-dose regimens. No immune effector cell-associated neurotoxicity syndrome events were observed. The poster will be posted in the "Resources & Publications" section of the company's website following the presentation.
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