Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLN-978 · 4 trials · 8 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)
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs); incidence of dose interruptions and delays
Dose-limiting Toxicities (DLTs)
| 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 |
| Part B Dose Expansion | EXPERIMENTAL | Patients with R/R DLBCL, R/R FL and other R/R B-NHL treated with CLN-978 at a dose selected from the Part A Dose Escalation arm. |
| 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...
CLN-978 is an investigational CD19-directed T cell engager being studied in Phase 1 trials for systemic lupus erythematosus (SLE), non-Hodgkin lymphoma (NHL), rheumatoid arthritis (RA), and Sjögren's disease. It is administered subcutaneously and is being developed by Cullinan Therapeutics, Inc. (NASDAQ: CGEM).
CLN-978 targets CD19, a protein found on B cells. As a CD19-directed T cell engager, it is designed to bring T cells into contact with CD19-expressing cells. This mechanism is being investigated across autoimmune conditions like SLE, RA, and Sjögren's disease, as well as in B cell NHL.
CLN-978 is being developed by Cullinan Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CGEM. The company is conducting Phase 1 clinical trials of CLN-978 in multiple indications, including SLE, rheumatoid arthritis, Sjögren's disease, and non-Hodgkin lymphoma.
CLN-978 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Active Phase 1 trials are recruiting or ongoing for SLE, rheumatoid arthritis, and Sjögren's disease, while a Phase 1 trial in relapsed or refractory B cell NHL is active but not recruiting.
CLN-978 is being studied in four Phase 1 trials. NCT05879744 is for relapsed or refractory B cell NHL (90 participants). NCT06613360 is for systemic lupus erythematosus (24 participants). NCT06994143 is for rheumatoid arthritis (37 participants). NCT07041099 is for Sjögren's disease (36 participants). All are open-label, non-randomized studies.
Yes, CLN-978 is described as a subcutaneously administered CD19-directed T cell engager. It is designed to engage T cells to target CD19-expressing cells. This mechanism is being evaluated in both oncology (B cell NHL) and autoimmune indications such as SLE, RA, and Sjögren's disease.