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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Cabaletta Bio
Study ID
NCT06328777
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CABA-201 — BIOLOGICAL
    Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

Study Details

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

Key Dates

Start date
Jul 2, 2024
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CABA-201
    Severe Skin Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with severe skin involvement Organ Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with organ involvement

Primary Outcome Measure

To evaluate incidence of adverse events [ Time Frame: Up to 28 days after CABA-201 infusion ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06519
Stephanie Perez
[email protected]
860-992-2908
Dr. Monique Hinchcliff, MD, MS (PRINCIPAL_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida55905
Wesley Dillinger
[email protected]
904-953-4511
Dr. Andy Abril, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
Kaitlin King
[email protected]
312-695-0990
Dr. George Georges, MD (PRINCIPAL_INVESTIGATOR)
The University of Chicago Medical CenterChicagoIllinois60637
Dequana Jones
[email protected]
773-834-5726
Dr. Michael Macklin, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Theresa Howard
[email protected]
913-588-0653
Dr. Paul Schmidt, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Lynne Bischoff
[email protected]
[email protected]
Monalisa Ghosh, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Christi Sagen
[email protected]
507-422-3425
Ashima Makol, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Gaby Ycaza
[email protected]
212-342-2751
Elana Bernstein, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642
Chelsey LoMonaco
[email protected]
585-402-2916
Benjamin Korman, M.D. (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Khalia Stewart
[email protected]
919-660-2280
Michelle Mack
[email protected]
919-613-1107
Ankoor Shah, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTMayo Clinic Florida· Jacksonville, FLNorthwestern Memorial Hospital· Chicago, ILThe University of Chicago Medical Center· Chicago, ILUniversity of Kansas Medical Center· Kansas City, KSUniversity of Michigan· Ann Arbor, MI

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