A Phase 1/2 interventional study of DSG3-CAART and CABA-201 in Pemphigus Vulgaris, sponsored by Cabaletta Bio. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Cabaletta Bio · Phase 1/2, Interventional, and Treatment
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
Pemphigus vulgaris (PV) is a B-cell mediated autoimmune disorder in which painful blisters are formed on the skin or mucosal membrane, including the mouth, nose, throat, eyelids, anus, and genitals.
This phase 1/2 study is being conducted in two parts. The first part is the main study conducted to find the maximum tolerated dose and optimal fractionated infusion schedule of an investigational cell therapy, DSG3-CAART, that can be given to patients with mucosal PV who are inadequately managed by standard therapies. This study is closed to enrollment.
The second part is a sub-study is being conducted to investigate if CABA-201, also called resecabtagene autoleucel, or "rese-cel", can be safely administered while achieving clinical responses without the need for preconditioning in mucosal-dominant PV (mPV) and mucocutaneous PV (mcPV) patients. This sub-study is open to enrollment.
DSG3-CAART or CABA-201 may potentially lead to complete and durable remission of disease.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Cabaletta Bio is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for DSG3-CAART: Closed to enrollment
Inclusion Criteria for CABA-201 sub-study: Open to enrollment
Exclusion Criteria:
Exclusion Criteria for CABA-201 sub-study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single or multiple intravenous infusion(s) of DSG3-CAART at varying dose levels. This study is now closed to enrollment.
Biological: DSG3-CAART
Infusion of CABA-201 with or without cyclophosphamide and fludarabine preconditioning, or with or without cyclophosphamide preconditioning. This sub-study is open to enrollment.
Biological: CABA-201
Intravenous infusions of DSG3-CAART alone at different doses and different fractionations, with or without intravenous immunoglobulin, cyclophosphamide, and/or fludarabine.
Single intravenous infusion of CABA-201 at escalating doses, with or without preconditioning.
Adverse events, including Dose Limit Toxicity
Incidence of adverse events that are related to DSG3-CAART therapy
Time frame: 3 months
For CABA-201 Sub-study: To evaluate adverse events reported by subjects
Incidence and severity of AEs
Time frame: Up to 28 days after CABA-201 infusion
Percent of CAAR-transduced cells
Percent of total cells for infusion that are CAAR-transduced cells by flow cytometry
Time frame: Baseline
Total DSG3-CAART positive cells
Total DSG3-CAART positive cells for each manufacturing run by flow cytometry
Time frame: Baseline
Cellular kinetics profile of DSG3-CAART
Cellular kinetics profile of DSG3-CAART assessed by quantitative polymerase chain reaction
Time frame: Up to 36 months
Change in DSG3 autoantibody titer
Change in DSG3 autoantibody titer by ELISA compared to pre-infusion visit
Time frame: Up to 36 months
Serologic remission
Proportion of subjects achieving serologic remission, determined by negative DSG3 ELISA titer
Time frame: Up to 36 months
Pemphigus Disease Area Index (PDAI)
Change in PDAI compared to pre-infusion visit, scored on a 0-250 scale where a greater number represents more disease activity
Time frame: Up to 36 months
Clinical remission: complete remission off therapy and complete remission on minimal therapy
Proportion of subjects achieving complete remission, determined by a PDAI activity score of 0 for at least 2 months, either off therapy or on minimal therapy
Time frame: Up to 36 months
Time to clinical remission and time to serologic remission
Time to clinical remission and time to serologic remission from the last infusion
Time frame: up to 36 months
Duration of clinical remission and duration of serologic remission
Duration of clinical remission and duration of serologic remission sustained after achieving the initial remission
Time frame: up to 36 months
For CABA-201 Sub-study: To evaluate adverse events reported by subjects
Incidence and severity of AEs
Time frame: Up to 156 weeks after CABA-201 infusion
For CABA-201 Sub-study: To characterize the pharmacodynamics (PD)
Levels of B cells in the blood
Time frame: Up to 156 weeks
For CABA-201 Sub-study: To characterize the pharmacokinetics (PK)
Levels of CABA-201-positive T cells in the blood
Time frame: Up to 156 weeks
For CABA-201 Sub-study: To evaluate autoantibody -related biomarkers
Levels of serum anti-DSG3 and anti-DSG1 antibodies
Time frame: Up to 156 Weeks
For CABA-201 Sub-study: To evaluate efficacy
Absolute and percent change in disease activity by Pemphigus Disease Area Index (PDAI)
Time frame: Up to 156 Weeks
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
Started Sep 2020 (actual). Primary completion is estimated for Jan 2029, 100 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Autologous Anti-CD19 CAR-T Cells CABA-201
Cabaletta Bio