A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCullinan Therapeutics Inc.
About this trial
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
Eligibility criteria
Qualifiers
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.
Absolute lymphocyte count (ALC) ≥0.5 × 10^9/L
Peripheral CD19+ B cell count ≥25 cells/µL
Disqualifiers
None
Trial design
Treatments tested in this trial
- CLN-978
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov