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Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis

StatusActive, Not Recruiting
PhasePhase 2
Started2024-10-29
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
Study Status, Contacts/Locations v18
Enrollment closed, study ongoing
Study sites94→93
2026-08-18
Study Status, Contacts/Locations v17
Study sites92→94
2026-07-07
Study Status, Contacts/Locations v16
Trial sites expanded: 87 → 92 locations
2026-06-02
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 87 sites
2026-05-12
Study Status, Contacts/Locations v14
Trial sites expanded: 80 → 87 locations
Show 13 earlier versions
2026-02-18
Study Status, Arms and Interventions, Contacts/Locations v13
Study sitesdetails revised at 1 of 80 sites
2026-02-03
Study Status, Study Design, Eligibility, Contacts/Locations v12
Enrollment target86→96
Study sites66→80
Eligibility criteria+126 characters
[...] temic sclerosis-associated cardiac involvement at Screening All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients. Exclusion Criteria: Any condition during Screening that coul [...]
2025-10-29
Study Status, Contacts/Locations v11
Study sites55→66
2025-09-29
Study Status, Contacts/Locations v10
Primary completion date2028-12-15→2028-11-30
Completion date2032-10-13→2032-08-30
Study sites47→55
2025-07-28
Study Status, Contacts/Locations v9
Study sites43→47
2025-06-27
Study Status, Contacts/Locations v8
Study sites42→43
2025-06-03
Study Status, Contacts/Locations v7
Study sites39→42
2025-05-26
Study Status, Study Description, Contacts/Locations v6
Study sites37→39
Study description+1 characters
[...] nce the participant is confirmed to be eligible per protocol. After end of study, participants who received rapcabtagene a [...]
2025-05-19
Study Status, Study Description, Contacts/Locations v5
Study sites35→37
Study description+180 characters
[...] rticipants to receive rapcabtagene autoleucel or rituximab. Participants in the rituximab arm whose disease is not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible per protocol After end of study, participants who received rapcabtagene a [...]
2025-05-08
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v4
Completion date2030-12-17→2032-10-13
Study sites17→35
Eligibility criteria-68 characters
[...] xcept secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sine sclero [...] onary hypertension. Significant renal pathology at Screening, including:. Active SSc renal crisis Confirmed diagnosis of glomerulonephritis Participants with uncontrolled stage II hypertension at Scre [...]
Secondary endpoints5 to 4 entries
Achievement of Week 156 progression-free survival with respect to disease progression criteria.
Study description-25 characters
This is a phase 2, multi-part, threefive-year, randomized, open-label, assessor-blinded, multicenter [...] cel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
2025-01-24
Study Status, Contacts/Locations v3
Study sites12→17
2024-12-19
Study Status, Contacts/Locations v2
Study sites2→12
2024-11-18
Study Identification, Study Status v1
Start dateestimated 2024-10-30→confirmed 2024-10-29
2024-10-22
Original filing
Novartis
552 trials monitored
See 32 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.
Trial Details
NCT Number NCT06655896
Lead Sponsor Novartis Pharmaceuticals
Conditions Scleroderma, Diffuse
Enrollment 96 participants
Start Date 2024-10-29
Primary Completion 2028-11-30 (estimated)
Study Completion 2032-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-02