Alnuctamab for Refractory SLE (LATTE Study)
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT07219563
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Alnuctamab — DRUGThe study drug will be given as an injection under the skin. For the first 9 days after the CC-93269 injection, subjects will be staying in the hospital. The goal of this study is to determine the optimal dose of CC-93269 to be safely administered to participants.
Study Details
This study will assess the safety and preliminary efficacy of the bi-specific TCE, alnuctamab (known as BMS-986349, CC-93269, EM901), targeting BCMA in patients with moderate to severe SLE, refractory to standard-of-care treatments.
Key Dates
- Start date
- Mar 17, 2026
- Status verified
- Feb 2026
- Primary completion
- Dec 1, 2027
- Completion
- Dec 1, 2027
Study Design
- Enrollment
- 21 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants with LupusThis study drug will be done by sentinel dosing (study drug given to a small number of participants to watch closely) before all the participants receive the study drug.
Primary Outcome Measure
Number of treatment emergent AEs [ Time Frame: 9 days ]
Central Contacts
- Chrisanna Dobrowolski, MD212-241-1671
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Chrisanna Dobrowolski (PRINCIPAL_INVESTIGATOR) |
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