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Cullinan Reports Early Phase 1 Data on CLN-978 and Velinotamig in Small Cohorts of RA and SLE Patients
The Cambridge-based company released Phase 1 results showing remissions in rheumatoid arthritis and lupus patients. Plans for Phase 2a expansion and additional trials were also outlined.
Jun 10, 7:30 AM·2m read2 sources
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Cullinan Therapeutics, Inc. reported new multi-dose clinical data on June 10, 2026, for CLN-978 in rheumatoid arthritis and systemic lupus erythematosus and for velinotamig in refractory SLE. 2 at week 4 and remaining at that level through week 8.
The remission coincided with rapid reduction in RA-associated autoantibodies. Data cutoff for CLN-978 was May 20, 2026. Safety observations from the first three multi-dose SLE patients in the Phase 1 OUTRACE SLE trial matched the profile seen in the initial RA cohort.
Patients with nephritis showed rapid improvement in proteinuria. The company plans to begin a Phase 2a expansion of CLN-978 in lupus nephritis in early 2027 and will report further multi-dose data for RA in Q3 2026 and for SLE in Q4 2026. For velinotamig, the first two refractory SLE patients completed four intravenous doses—3 µg/kg on day 1 followed by three doses of 10 µg/kg—with a data cutoff of May 15, 2026.
Both patients recorded rapid, marked reductions in SLEDAI-2K scores and proteinuria and achieved complete renal response. SLE patient 1 improved from a baseline SLEDAI-2K score of 16 to 0 at week 8; SLE patient 2 improved from 14 to 2. No cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome occurred.
Clinical improvements aligned with pharmacodynamic changes consistent with the drug’s mechanism. Cullinan Therapeutics plans to release additional multi-dose data from the Genrix Bio trial of velinotamig in China in Q4 2026. The company also intends to start a Phase 1/2a trial in Q1 2027 for patients with autoimmune cytopenias, including immune thrombocytopenia and autoimmune hemolytic anemia.
Nadim Ahmed, President and Chief Executive Officer of Cullinan Therapeutics, said the data support development of differentiated CD19 and BCMA T cell engagers for B cell– and plasma cell–driven autoimmune diseases and the potential for durable, treatment-free remissions in an outpatient setting. m. ET.
