Trials / Not Yet Recruiting
Not Yet RecruitingNCT07006805
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
RESET-MS: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Participants With Multiple Sclerosis
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Cabaletta Bio · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis
Detailed description
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability, and efficacy of different doses of CABA-201 in adult participants with MS to determine an appropriate dose for future studies. Any participant who receives CABA-201 will be followed after infusion for 156 weeks. Two cohorts of participants will be studied based upon their MS diagnosis. * Relapsing MS Cohort (RMS Cohort): Participants with active relapsing MS, including relapsing remitting MS (RRMS) and relapsing secondary progressive MS (SPMS) that is treatment-resistant * Progressive MS Cohort (PMS Cohort): Participants with worsening progressive MS, including primary progressive MS (PPMS) or non-relapsing SPMS that is treatment-resistant The study will consist of 2 parts: Part A (dose escalation) and Part B (dose expansion).
Conditions
- Relapsing Multiple Sclerosis (RMS)
- Progressive Multiple Sclerosis (PMS)
- Multiple Sclerosis - Relapsing Remitting
- Multiple Sclerosis
- Multiple Sclerosis (Relapsing Remitting)
- Multiple Sclerosis (MS) - Relapsing-remitting
- Progressive Multiple Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CABA-201 | Single intravenous infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2028-09-01
- Completion
- 2029-10-01
- First posted
- 2025-06-05
- Last updated
- 2025-10-31
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07006805. Inclusion in this directory is not an endorsement.