Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06613360 | A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus | PHASE1 | RECRUITING | 24 | — | — | Jan 21, 2025 | Dec 1, 2027 | Jun 5, 2026 | 20 | United States, Australia +5 |
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 SLE treated with CLN-978 in dose escalation cohorts |
| Part B Further Dose Evaluation | EXPERIMENTAL | Further evaluation of CLN-978 treatment of patients with SLE |
| Name | Type | Description |
|---|---|---|
| CLN-978 | DRUG | Specified dose on specified days |
Inclusion Criteria: * Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening. * Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear anti...