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RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis

StatusRecruiting
PhasePhase 1/2
Started2024-12-17
View on ClinicalTrials.gov ↗

Amendment history

2026-08-12
Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v32
Enrollment reopened
Enrollment increased: 12 → 24 participants
Trial arms changed: 1 → 2
InterventionsCABA-201 (Biological)→CABA-201 (Biological), CABA-201 (Biological)
Study description+108 characters
[...] clophosphamide (CY) and fludarabine (FLU) will be evaluated. In addition, escalating doses of CABA-201 will be evaluated in patients without CY and FLU preconditioning.
Study sitesdetails revised at 17 of 17 sites
2026-05-14
2 amendments v30-v31
2 re-verifications since 2026-05-13, no change to tracked fields
2026-02-19
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v29
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 17 of 17 sites
2026-01-14
Study Status, Contacts/Locations v28
Study sites14→17
2025-09-25
Study Status, Contacts/Locations v27
Study sitescontacts updated at 1 of 14 sites
Show 26 earlier versions
2025-08-04
Study Status, Contacts/Locations v26
Study sitesdetails revised at 1 of 14 sites
2025-07-15
Study Status, Contacts/Locations v25
Study sitescontacts updated at 1 of 14 sites
2025-06-13
Study Status, Contacts/Locations v24
Study sitesdetails revised at 2 of 14 sites
2025-06-12
Study Status, Contacts/Locations v23
Study sites13→14
2025-06-03
Study Status, Contacts/Locations v22
Study sitescontacts updated at 1 of 13 sites
2025-05-29
Study Status, Contacts/Locations v21
Study sites11→13
2025-05-14
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 11 sites
2025-04-23
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 11 sites
2025-04-21
Study Status, Contacts/Locations v18
Study sites10→11
2025-04-04
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 10 sites
2025-03-21
Study Status, Contacts/Locations v16
Study sites8→10
2025-03-18
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 8 sites
2025-02-28
Study Status, Contacts/Locations v14
Study sitesdetails revised at 1 of 8 sites
2025-02-19
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 8 sites
2025-02-11
Study Status, Contacts/Locations v12
Study sites7→8
2025-01-31
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 7 sites
2025-01-28
Study Status, Contacts/Locations v10
Study sites6→7
2025-01-23
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 6 sites
2025-01-15
Study Status, Contacts/Locations v8
Start dateestimated 2024-12→confirmed 2024-12-17
Study sites4→6
2024-12-09
Study Status, Contacts/Locations v7
Start date2024-10→2024-12
Study sites3→4
2024-09-27
Study Status, Contacts/Locations v6
Start date2024-08→2024-10
Study sites2→3
2024-08-21
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 2 sites
2024-07-19
Study Status, Contacts/Locations v4
Re-verified, no change to tracked fields
2024-07-15
Study Status, Contacts/Locations v3
Study sites1→2
2024-06-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2024-04-24
Study Status v1
Primary completion date2028-07→2029-09
Completion date2028-07→2029-09
Start date2024-05→2024-08
2024-04-05
Original filing
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
Trial Details
NCT Number NCT06359041
Lead Sponsor Cabaletta Bio
Conditions Generalized Myasthenia Gravis (gMG)
Enrollment 24 participants
Start Date 2024-12-17
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-13