Cullinan Therapeutics, Inc. filed a current report on Form 8-K on November 9, 2026, disclosing interim clinical data from an ongoing Phase 1b/2a trial of velinotamig in patients with active, refractory, moderate-to-severe systemic lupus erythematosus, as presented at the American College of Rheumatology Convergence 2026 on November 8, 2026.

Key Highlights

  • 12 patients treated: As of the September 8, 2026 data cutoff, 12 patients had been treated across three multi-dose cohorts in the Genrix-conducted trial in China.
  • No dose-limiting toxicities: The filing reports no dose-limiting toxicities, no ICANS, and no Grade 3 or higher cytokine release syndrome observed.
  • CRS limited to Grade 1 or 2: CRS occurred in two patients, resolved with standard management, and no Grade 2 events were observed after modifications to the step-up dosing regimen.
  • Eight of nine evaluable patients: Among the first nine patients with at least four weeks of follow-up, eight of nine evaluable patients achieved a reduction of at least four points in SLEDAI-2K.
  • Renal response in four patients: Among seven evaluable patients with urine protein excretion greater than 500 mg/24 hours at baseline, four achieved a complete renal response with proteinuria below 500 mg/24 hours within 24 weeks.
  • License held by Cullinan: According to the filing, the company holds a global (ex-Greater China), all-indication, exclusive license to develop velinotamig from Chongqing Genrix Biopharmaceutical Co., Ltd.

Interim Velinotamig Trial Results in SLE Patients Presented at ACR Convergence 2026

Cullinan Therapeutics, Inc. (NASDAQ:CGEM) disclosed interim Phase 1b/2a clinical data for velinotamig in an 8-K filing dated November 9, 2026, covering an event of November 8, 2026. The data originate from a trial being conducted by Chongqing Genrix Biopharmaceutical Co., Ltd. in China and were presented at the American College of Rheumatology Convergence 2026. According to the filing, the company holds a global (ex-Greater China), all-indication, exclusive license to develop velinotamig from Genrix.

The filing reports that as of the September 8, 2026 data cutoff, 12 patients had been treated across three multi-dose cohorts. The company disclosed that velinotamig "demonstrated a favorable safety profile," with no dose-limiting toxicities, no immune effector cell-associated neurotoxicity (ICANS), and no Grade 3 or higher cytokine release syndrome. CRS was reported in two patients and was limited to Grade 1 or Grade 2 events that resolved with standard management. The filing further states that no Grade 2 events were observed after modifications to the step-up dosing regimen.

Among the first nine patients with at least four weeks of follow-up, the filing reports clinical activity across measures of disease activity, serologic markers, and renal function. Eight of nine evaluable patients achieved a clinically meaningful reduction of at least four points in SLEDAI-2K. Among seven evaluable patients with urine protein excretion greater than 500 mg/24 hours at baseline, five experienced rapid and marked reductions in proteinuria, and four of these patients achieved a complete renal response as demonstrated by proteinuria levels below 500 mg/24 hours within 24 weeks. Reductions in anti-double-stranded DNA antibodies and blood IgG, improvement in complement C3, and depletion of CD19-positive B cells were also reported. The filing notes these data are interim, subject to change, and "based on data available as of a specified date," and that the company's forward-looking statements are subject to its cautionary language and known and unknown risks.

What Was Disclosed

Cullinan Therapeutics filed an 8-K on November 9, 2026, reporting interim Phase 1b/2a safety and efficacy data for velinotamig in SLE patients from a Genrix-conducted trial in China, as presented at ACR Convergence 2026 on November 8, 2026.