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

StatusRecruiting

PhasePhase 2/3

SponsorCabaletta Bio

Started2024-07-02

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary endpoint added 1 → 2 primary endpoints

See other at-risk trials from Cabaletta Bio

Amendment history

2026-08-14

Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v30

Phase changed: Phase 1/2 → Phase 2/3

Primary endpoint(s) modified1 to 2 entries

WasTo evaluate incidence of adverse events

NowPhase 1/2: To evaluate incidence of adverse events, Phase 2b Sub-study: To evaluate the efficacy of CABA-201 on % predicted forced vital capacity (FVC) in SSc-ILD subjects

Enrollment increased: 12 → 37 participants

Trial arms changed: 1 → 2

InterventionsCABA-201 (Biological)→CABA-201 (Biological), CABA-201 (Biological)

Eligibility criteria-7 characters

[...] rly active disease Evidence of significant skin, pulmonary, ~~renal,~~ or cardiac involvement Exclusion Criteria: Contraindication [...]

Secondary endpoints4 to 5 entries

Mean change from baseline in Modified Rodnan Skin Score (mRSS)

2026-07-21

Study Status, Contacts/Locations v29

Study sitescontacts updated at 1 of 10 sites

2026-05-13

Study Status, Contacts/Locations v28

Study sitescontacts updated at 2 of 10 sites

2026-04-23

Study Status, Contacts/Locations v27

Study sitescontacts updated at 4 of 10 sites

2026-04-07

Study Status, Contacts/Locations v26

Study sitescontacts updated at 1 of 10 sites

Show 25 earlier versions

2025-09-25

Study Status, Contacts/Locations v25

Study sitescontacts updated at 1 of 10 sites

2025-05-20

Study Status, Contacts/Locations v24

Study sitesdetails revised at 2 of 10 sites

2025-05-05

Study Status, Contacts/Locations v23

Study sites9→10

2025-04-08

Study Status, Contacts/Locations v22

Study sitesdetails revised at 1 of 9 sites

2025-04-07

Study Status, Contacts/Locations v21

Study sites8→9

2025-03-28

Study Status, Contacts/Locations v20

Study sitescontacts updated at 1 of 8 sites

2025-03-19

Study Status, Contacts/Locations v19

Study sites7→8

2025-02-28

Study Status, Contacts/Locations v18

Study sitesdetails revised at 2 of 7 sites

2025-01-28

Study Status, Contacts/Locations v17

Study sites6→7

2025-01-14

Study Status, Contacts/Locations v16

Study sites5→6

2025-01-08

Study Status, Eligibility v15

Eligibility criteriarevised

Inclusion Criteria: Age ≥18 and ≤7075 A clinical diagnosis of SSc, based on the 2013 American Col [...]

2024-12-17

Study Status, Contacts/Locations v14

Study sitescontacts updated at 1 of 5 sites

2024-11-07

Study Status, Contacts/Locations v13

Study sitesdetails revised at 1 of 5 sites

2024-10-22

Study Status, Contacts/Locations v12

Study sitesdetails revised at 1 of 5 sites

2024-09-23

Study Identification, Study Status, Oversight, Contacts/Locations v11

Study sites4→5

Study titlerevised

RESET-SSc: anAn Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects ~~with~~With Systemic Sclerosis

2024-09-11

Study Identification, Study Status, Oversight, Contacts/Locations v10

Study sites3→4

Study titlerevised

RESET-SSc: Anan Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects ~~With~~with Systemic Sclerosis

2024-08-27

Study Status v9

Start dateestimated 2024-09→confirmed 2024-07-02

2024-08-22

Study Status, Contacts/Locations v8

Study sites2→3

2024-08-19

Study Status, Contacts/Locations v7

Start date2024-07→2024-09

Study sitesdetails revised at 1 of 2 sites

2024-07-19

2 amendments v5-v6

2 re-verifications since 2024-07-15, no change to tracked fields

2024-07-08

Study Status, Contacts/Locations v4

Start date2024-06→2024-07

Study sites1→2

2024-06-06

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3

Trial statusNot Yet Recruiting→Recruiting

Study sitesdetails revised at 1 of 1 site

2024-04-25

Study Status, Contacts/Locations v2

Study sites0→1

2024-03-28

Study Identification, Study Status v1

Study title-9 characters

RESET-SSc: ~~A Phase 1/2~~An Open-Label Study to Evaluate the Safety and Efficacy of CAB [...]

2024-03-19

Original filing

Cabaletta Bio

6 trials monitored

See 1 trial at risk

Scleroderma

302 trials monitored

See 9 trials at risk

RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis

Trial Details

NCT Number	NCT06328777
Lead Sponsor	Cabaletta Bio
Conditions	Systemic Sclerosis, Scleroderma, Interstitial Lung Diseases
Enrollment	37 participants
Start Date	2024-07-02
Primary Completion	2029-07 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-17