A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Part of paid clinical trials in Avondale, Arizona.
- Sponsor
- Cullinan Therapeutics Inc.
- Study ID
- NCT06613360
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- SLE
- SLE (Systemic Lupus)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- CLN-978 — DRUGSpecified dose on specified days
Study Details
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Key Dates
- Start date
- Jan 21, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A Dose EscalationPatients with SLE treated with CLN-978 in dose escalation cohorts
- Experimental: Part B Further Dose EvaluationFurther evaluation of CLN-978 treatment of patients with SLE
Primary Outcome Measure
Safety and tolerability [ Time Frame: 48 weeks ]
Central Contacts
- Meagan Sardinha+1 617 410 4650
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AARA Clinical Research | Avondale | Arizona | 85392 | |
| AARA Clinical Research | Tucson | Arizona | 85704 | |
| Omega Research Group | Orlando | Florida | 32808 | |
| University of Iowa | Iowa City | Iowa | 52242 | |
| Columbia University Medical Center | New York | New York | 10032 | - |
| University of Rochester Medical Center | Rochester | New York | 14642 | |
| Regional One Health | Memphis | Tennessee | 38103 | |
| Stryde Research | Plano | Texas | 75093 | |
| Tranquil Clinical Research | Webster | Texas | 77598 | |
| Intermountain Health | Salt Lake City | Utah | 84101 |
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