COMPANY
Cabaletta Bio
Timeline
- Trial start Phase 1/Phase 2: RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis source ↗
- Raise Follow-on offering: $150M (total, as published), announced May 4, 2026. Source: SEC filing. source ↗
- Raise Follow-on offering: $100M (total, as published), announced Jun 11, 2025. Source: SEC filing. source ↗
- Trial start Phase 1/Phase 2: RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis source ↗
- Trial start Phase 2/Phase 3: RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis source ↗
- Trial start 1: RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus source ↗
- Trial start Phase 2/Phase 3: RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopat source ↗
- Trial start Phase 1: Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myasthenia Gravis source ↗
- Trial start 1: A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA- source ↗
Upcoming milestones
- 2028-07 (ESTIMATED) · Phase 2/Phase 3 · RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy · NCT06154252
- 2029-01 (ESTIMATED) · 1 · A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201 · NCT04422912
- 2029-07 (ESTIMATED) · Phase 2/Phase 3 · RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis · NCT06328777
- 2029-09 (ESTIMATED) · Phase 1/Phase 2 · RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis · NCT06359041
- 2029-12 (ESTIMATED) · 1 · RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus · NCT06121297
Funding
Clinical trials (lead sponsor) 7
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06359041 | RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis | Phase 1/Phase 2 | Recruiting | Dec 17, 2024 | 2029-09 (estimated) |
| NCT06121297 | RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus | 1 | Recruiting | Feb 16, 2024 | 2029-12 (estimated) |
| NCT06154252 | RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy | Phase 2/Phase 3 | Recruiting | Dec 20, 2023 | 2028-07 (estimated) |
| NCT06328777 | RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis | Phase 2/Phase 3 | Recruiting | Jul 2, 2024 | 2029-07 (estimated) |
| NCT07006805 | RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis | Phase 1/Phase 2 | Withdrawn | 2026-06 | 2028-09 (estimated) |
| NCT04422912 | A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV) | 1 | Recruiting | Sep 29, 2020 | 2029-01 (estimated) |
| NCT05451212 | Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myasthenia Gravis | Phase 1 | Completed | Nov 23, 2022 | Jul 24, 2025 (actual) |
Raises and investors new
- InvestorListed in the portfolio of Bain Capital Life Sciences (captured Oct 12, 2026). portfolio page ↗