What this study is
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
What's being tested
- DSG3-CAART
Intervention · BIOLOGICAL
Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine.
- CABA-201
Intervention · BIOLOGICAL
Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.
Study details
- Official title
- 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
- Sponsor
- Cabaletta Bio
- Conditions
- Pemphigus Vulgaris
- Enrolling
- 40 people
- Starts
- 2020-09-29
- Est. completion
- 2029-01
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA
- mPV inadequately managed by at least one standard immunosuppressive therapies
- Active mPV at screening
- Anti-DSG3 antibody ELISA positive at screening Inclusion Criteria for CABA-201 sub-study: Open to enrollment
- Age ≥18
- Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and/or DIF
- PV inadequately managed by at least one standard immunosuppressive therapy
- Active PV at screening
- DSG3 ELISA positive at screening
You can't join if
- Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease
- Rituximab in last 12 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased
- Prednisone > 0.25mg/kg/day
- Other autoimmune disorder requiring immunosuppressive therapies
- Investigational treatment in last 3 months
- Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer) or malignancy diagnosed within the previous 5 years
- Have received rituximab or other anti-CD20 or anti-CD19 therapies in last 12 months unless anti-DSG3 antibody titers have recently increased or PV symptoms have recently worsened
- Prednisone > 0.25mg/kg/day
- Other autoimmune disorder requiring immunosuppressive therapies
- Treatment with any investigational agent within 4 weeks or 5 half-lives, whichever is longer.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (13)
10 openStanford University, Dept. of Dermatology
Redwood City, California, United States
- Kunju Sridhar, PhD · Contact650-721-4902kunju@stanford.edu
- M. Peter Marinkovich, MD · Principal investigator
RecruitingUC Davis, Dept. of Dermatology
Sacramento, California, United States
- Lauren Downing · Contact916-551-2635ladowning@ucdavis.edu
- Mehrdad Abedi, MD · Principal investigator
RecruitingYale University
New Haven, Connecticut, United States
- Kacie Carlson · Contact203-785-7432kacie.carlson@yale.edu
- Mary Tomayko, MD, PhD · Principal investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
- NU Dermatology CTU · Contact312-503-5944NUderm-research@northwestern.edu
- Alan Zhou, MD · Principal investigator
RecruitingUniversity of Iowa
Iowa City, Iowa, United States
- Amanda Howell · Contact319-384-6843amanda-steahr@uiowa.edu
- Emma Killoran, MD · Principal investigator
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
- Sydney Chase · Contact617-525-7638schase@bwh.harvard.edu
- Rebecca Wenzel-Rideout · Contactrwenzel-rideout@bwh.harvard.edu
- Arash Mostaghimi, MD, MPH, FAAD · Principal investigator
RecruitingColumbia University
New York, New York, United States
- Hei Ton "Jason" Chan · Contact646-317-6360htc2110@cumc.columbia.edu
- Alexandra Coromilas, MD · Principal investigator
RecruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Marie DeMarco · Contact215-349-5699marie.demarco@pennmedicine.upenn.edu
- David Porter, MD · Principal investigator
RecruitingUT Southwestern Medical Center, Dept. of Dermatology
Dallas, Texas, United States
- Aleuna Lee · Contact214-645-8968aleuna.lee@utsouthwestern.edu
- Arturo Dominguez, MD · Principal investigator
RecruitingMD Anderson Texas Medical Center
Houston, Texas, United States
- Alda Ashu · Contact713-792-1280abmiraso@mdanderson.org
- Omar Pacha, MD · Principal investigator
RecruitingMount Sinai - Icahn School of Medicine
New York, New York, United States
WithdrawnUniversity of North Carolina, Department of Dermatology
Chapel Hill, North Carolina, United States
WithdrawnUniversity of Washington
Seattle, Washington, United States
Completed
Study team
Sponsor
Cabaletta Bio
Study ID CAB-101
Study chair
Cabaletta Bio
Cabaletta Bio
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.