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CLN-978 · 3 trials · 6 indications
Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
| Arm | Type | Description |
|---|---|---|
| Part A Dose Escalation | EXPERIMENTAL | Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts |
| Part B Further Dose Evaluation | EXPERIMENTAL | Further evaluation of CLN-978 treatment of patients with Sjogren's Disease |
| Part A: Dose Escalation | EXPERIMENTAL | Patients with RA treated with CLN-978 in dose escalation cohorts |
| Name | Type | Description |
|---|---|---|
| CLN-978 | DRUG | Specified dose on specified days |
Inclusion * Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening. * Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening. * Laboratory parameters including the following: * Absolute lymphocyte coun...
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CLN-978 is an investigational subcutaneous CD19-directed T cell engager being developed by Cullinan Therapeutics for autoimmune and inflammatory diseases. It is in Phase 1 clinical development for rheumatoid arthritis, systemic lupus erythematosus, and Sjögren's disease. It is a small molecule that binds CD19, a protein target on B cells.
CLN-978 is being studied in Phase 1 for rheumatoid arthritis, along with systemic lupus erythematosus and Sjögren's disease. The rheumatoid arthritis trial, NCT06994143, is recruiting adults 18 years and older in Germany and Italy. CLN-978 is investigational and has not been approved for any indication.
CLN-978 targets CD19, a protein on the surface of B cells. It is designed as a CD19-directed T cell engager, given subcutaneously, that redirects T cells toward CD19-expressing cells. CD19 is the molecular target of the program, which Cullinan Therapeutics is developing in immunology.
CLN-978 is developed by Cullinan Therapeutics, Inc., which trades on Nasdaq under the ticker CGEM. The company is running Phase 1 studies of the subcutaneous CD19-directed T cell engager in rheumatoid arthritis, systemic lupus erythematosus, and Sjögren's disease across sites in the United States and Europe.
CLN-978 is in Phase 1 clinical development. All three of its studies, in rheumatoid arthritis, systemic lupus erythematosus, and Sjögren's disease, are currently recruiting participants. CLN-978 is investigational and has not been approved by the FDA for any indication.
CLN-978 is in three recruiting Phase 1 trials: NCT07041099 in Sjögren's disease across the United States, France, Germany, and Italy; NCT06994143 in rheumatoid arthritis in Germany and Italy; and NCT06613360 in systemic lupus erythematosus across the United States, Australia, and several European countries. All enroll adults 18 and older.