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 small molecule being developed for relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL) and for the autoimmune conditions systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjogren's disease. It is a CD19-directed T cell engager administered subcutaneously.
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 studied across both oncology and autoimmune indications.
CLN-978 is being developed by Cullinan Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker CGEM. The company is conducting Phase 1 clinical trials of CLN-978 in multiple indications.
CLN-978 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Multiple Phase 1 trials are ongoing or active across different indications, including non-Hodgkin lymphoma, SLE, rheumatoid arthritis, and Sjogren's disease.
CLN-978 is being studied in four Phase 1 trials: NCT05879744 for relapsed or refractory B cell non-Hodgkin lymphoma, NCT06613360 for systemic lupus erythematosus, NCT06994143 for rheumatoid arthritis, and NCT07041099 for Sjogren's disease. The lymphoma trial is active but not recruiting, while the others are recruiting.
Yes, CLN-978 is a CD19-directed T cell engager. It is designed to target CD19 on B cells and is administered subcutaneously. This mechanism is being evaluated in both oncology and autoimmune disease clinical trials.