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Tests treatment safety and results for Pemphigus Vulgaris
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 (RESET-PV)
ClinicalTrials.gov ID: NCT04422912
What this study is testing
What is DSG3-CAART?
DSG3-CAART is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pemphigus vulgaris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for DSG3-CAART: Closed to enrollment
- 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 for CABA-201 sub-study: Open to enrollment
You likely 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 Exclusion Criteria for CABA-201 sub-study
- Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer) or malignancy diagnosed within the previous 5 years
See the full eligibility criteria
- for DSG3-CAART: Closed to enrollment
- 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 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
- 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 Exclusion Criteria for CABA-201 sub-study
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- Sacramento, California, United States
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; Sacramento, California, United States; New Haven, Connecticut, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.