A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
Part of paid clinical trials in Orlando, Florida.
- Sponsor
- Cullinan Therapeutics Inc.
- Study ID
- NCT07041099
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Sjogren Disease
- Sjogren's Syndrome
- Sjögren
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CLN-978 — DRUGSpecified dose on specified days
Study Details
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
Key Dates
- First listed
- Jun 27, 2025
- Start date
- Oct 1, 2025
- Status verified
- Aug 2026
- Primary completion
- Mar 15, 2028
- Completion
- Mar 15, 2029
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A Dose EscalationPatients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts
- Experimental: Part B Further Dose EvaluationFurther evaluation of CLN-978 treatment of patients with Sjogren's Disease
Primary Outcome Measure
Safety and Tolerability [ Time Frame: 48 weeks ]
Central Contacts
- Amy Gubits, MPH+1 617 410 4650
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Omega Research | Orlando | Florida | 32808 | |
| New York University | Brooklyn | New York | 11201 | Abraham Sinay-Smith |
| Regional One | Memphis | Tennessee | 38103 | |
| Stryde Research | Plano | Texas | 75093 | |
| Tranquil Research | Webster | Texas | 77598 | |
| Intermountain | Salt Lake City | Utah | 84143 |
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