A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)

Part of paid clinical trials in Redwood City, California.

Sponsor
Cabaletta Bio
Study ID
NCT04422912
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Pemphigus Vulgaris

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DSG3-CAART — BIOLOGICAL
    Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine.
  • CABA-201 — BIOLOGICAL
    Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.

Study Details

A phase 1/2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells \[DSG3-CAART\] or CD19-specific Chimeric Antigen Receptor T cells \[CABA-201\]) in subjects with active, pemphigus vulgaris

Key Dates

Start date
Sep 29, 2020
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DSG3-CAART
    Single or multiple intravenous infusion(s) of DSG3-CAART at varying dose levels. This study is now closed to enrollment.
  • Experimental: CABA-201
    Infusion of CABA-201 with or without cyclophosphamide and fludarabine preconditioning, or with or without cyclophosphamide preconditioning. This sub-study is open to enrollment.

Primary Outcome Measure

Adverse events, including Dose Limit Toxicity [ Time Frame: 3 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Stanford University, Dept. of DermatologyRedwood CityCalifornia94063
Kunju Sridhar, PhD
[email protected]
650-721-4902
M. Peter Marinkovich, MD (PRINCIPAL_INVESTIGATOR)
UC Davis, Dept. of DermatologySacramentoCalifornia95816
Lauren Downing
[email protected]
916-551-2635
Mehrdad Abedi, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06520
Andrea DeClement
[email protected]
475-255-8031
Mary Tomayko, MD, PhD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
NU Dermatology CTU
[email protected]
312-503-5944
Alan Zhou, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Amanda Howell
[email protected]
319-384-6843
Emma Killoran, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Sydney Chase
[email protected]
617-525-7638
Rebecca Wenzel-Rideout
[email protected]
Arash Mostaghimi, MD, MPH, FAAD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Hei Ton "Jason" Chan
[email protected]
646-317-6360
Alexandra Coromilas, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai - Icahn School of MedicineNew YorkNew York10029-
University of North Carolina, Department of DermatologyChapel HillNorth Carolina27516-
University of PennsylvaniaPhiladelphiaPennsylvania19104
Marie DeMarco
[email protected]
215-349-5699
David Porter, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical Center, Dept. of DermatologyDallasTexas75235
Aleuna Lee
[email protected]
214-645-8968
Arturo Dominguez, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Texas Medical CenterHoustonTexas77030
Alda Ashu
[email protected]
713-792-1280
Omar Pacha, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98109-

Find similar trials in Redwood City, CA

By research site
Stanford University, Dept. of Dermatology· Redwood City, CAUC Davis, Dept. of Dermatology· Sacramento, CAYale University· New Haven, CTNorthwestern University· Chicago, ILUniversity of Iowa· Iowa City, IABrigham and Women's Hospital· Boston, MA

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