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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

StatusRecruiting
PhasePhase 1/2
Started2024-02-16
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 52 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-08-24
Study Status, Contacts/Locations v51
Study sitescontacts updated at 1 of 23 sites
2026-08-17
Study Status, Contacts/Locations v50
Study sitesdetails revised at 4 of 23 sites
2026-04-07
Study Status, Contacts/Locations v49
Study sitescontacts updated at 2 of 23 sites
2026-02-19
Study Status, Contacts/Locations v48
Study sitescontacts updated at 1 of 23 sites
2025-12-04
Study Status, Study Description, Study Design, Arms and Interventions v47
Primary completion date2027-12→2029-12
Completion date2027-12→2029-12
Enrollment target12→28
Study arms1→2
InterventionsCABA-201 (Biological)→CABA-201 (Biological), CABA-201 (Biological)
Study description+165 characters
[...] and efficacy of an investigational cell therapy, CABA-201, thatalso called resecabtagene autoleucel, or "rese-cel". Rese-cel can be given to patients with either LN or SLE without rena [...] in two separate parallel cohorts, who have active disease. AInitially a single dose of CABA-201 in patients who are pretreated with a standard regimen including cyclophosphamide (CY) and fludarabine (FLU), will be evaluated. In addition, escalating doses of CABA-201 will be evaluated in patients without CY and FLU pretreatment.
Show 45 earlier versions
2025-11-17
Study Status, Contacts/Locations v46
Study sitesdetails revised at 1 of 23 sites
2025-11-11
Study Status, Contacts/Locations v45
Study sites22→23
2025-10-03
Study Status, Contacts/Locations v44
Study sitesdetails revised at 1 of 22 sites
2025-10-03
Study Status, Contacts/Locations v43
Study sitescontacts updated at 1 of 22 sites
2025-09-25
Study Status, Contacts/Locations v42
Study sitescontacts updated at 2 of 22 sites
2025-09-02
Study Status, Contacts/Locations v41
Study sitescontacts updated at 1 of 22 sites
2025-07-18
Study Status, Contacts/Locations v40
Study sitesdetails revised at 1 of 22 sites
2025-06-16
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 22 sites
2025-04-10
Study Status, Contacts/Locations v38
Study sitesdetails revised at 1 of 22 sites
2025-03-25
Study Status, Contacts/Locations v37
Study sitescontacts updated at 2 of 22 sites
2025-03-24
Study Status, Contacts/Locations v36
Study sites21→22
2025-03-07
Study Status, Contacts/Locations v35
Study sitesdetails revised at 1 of 21 sites
2025-02-21
Study Status, Contacts/Locations v34
Study sitesdetails revised at 1 of 21 sites
2025-02-19
Study Status, Contacts/Locations v33
Study sites20→21
2025-02-11
Study Status, Contacts/Locations v32
Study sitescontacts updated at 1 of 20 sites
2025-01-14
Study Status, Contacts/Locations v31
Study sites19→20
2024-12-19
Study Status, Contacts/Locations v30
Study sitesdetails revised at 2 of 19 sites
2024-11-06
Study Identification, Study Status, Oversight, Contacts/Locations v29
Study sites17→19
Study titlerevised
RESET-SLE: aA Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects withWith Active Systemic Lupus Erythematosus
2024-09-05
Study Status, Contacts/Locations v28
Study sites16→17
2024-09-03
Study Identification, Study Status, Oversight, Contacts/Locations v27
Study sitesdetails revised at 16 of 16 sites
Study titlerevised
RESET-SLE: Aa Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects Withwith Active Systemic Lupus Erythematosus
2024-08-23
Study Status, Contacts/Locations v26
Study sitescontacts updated at 1 of 16 sites
2024-08-20
Study Status, Contacts/Locations v25
Study sites15→16
2024-08-12
Study Status, Contacts/Locations v24
Study sites14→15
2024-08-09
Study Status, Contacts/Locations v23
Study sites13→14
2024-07-19
Study Status, Contacts/Locations v22
Re-verified, no change to tracked fields
2024-06-24
Study Status, Contacts/Locations v21
Study sites12→13
2024-05-30
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 12 sites
2024-05-29
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 12 sites
2024-05-24
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 12 sites
2024-05-17
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 12 sites
2024-05-02
Study Status, Contacts/Locations v16
Study sites9→12
2024-05-01
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 9 sites
2024-04-29
Study Status, Contacts/Locations v14
Study sitesdetails revised at 1 of 9 sites
2024-03-29
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 9 sites
2024-03-19
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 9 sites
2024-02-27
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 9 sites
2024-02-26
Study Status, Contacts/Locations v10
Study sites8→9
2024-02-16
Study Status, Contacts/Locations v9
Start dateestimated 2024-01-26→confirmed 2024-02-16
Study sitescontacts updated at 1 of 8 sites
2024-02-02
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 8 sites
2024-01-29
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 8 sites
2024-01-23
Study Status, Contacts/Locations v6
Study sites6→8
2024-01-10
Study Status, Study Description v5
Start date2023-10-13→2024-01-26
2024-01-08
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 6 sites
2024-01-04
Study Identification, Study Status, Contacts/Locations v3
Study sites4→6
Study title+23 characters
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
2023-12-18
Study Status, Contacts/Locations v2
Start dateestimated 2023-11→confirmed 2023-10-13
Study sites1→4
Cabaletta Bio
6 trials monitored
See 1 trial at risk
Lupus (SLE)
648 trials monitored
See 25 trials at risk
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
Trial Details
NCT Number NCT06121297
Lead Sponsor Cabaletta Bio
Conditions Systemic Lupus Erythematosus, Lupus Nephritis
Enrollment 28 participants
Start Date 2024-02-16
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-26