Our RESETTM clinical trials with rese-cel (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, and pemphigus vulgaris are now recruiting.
CD19 CAR T Therapy Is Feasible in Patients with Pemphigus Vulgaris Treated Without Lymphodepletion in the RESET-PV Trial
ASH Publications | May 26, 2026
Lymphodepleting preconditioning (LD) is essential for the efficacy of CAR T therapy in hematologic malignancies. However, in the setting of autoimmune diseases (ADs), the contribution of LD for efficacy is unclear. Here, we report on the early safety, efficacy, and correlative data of the first four pemphigus vulgaris (PV) subjects who received resecabtagene autoleucel (rese-cel) a fully human CD19-CAR T cell therapy, without LD in the RESET-PV® trial (NCT04422912), a sub-study of the DesCAARTes trial. Following infusion, pemphigus disease area index (PDAI) scores improved significantly in all subjects. A favorable safety profile was observed with a single episode of grade 1 cytokine release syndrome. Immune-effector-cell-associated neurotoxicity was not observed. Rese-cel expansion was similar in PV subjects as compared to other rese-cel treated AD subjects who received LD. B cell depletion was observed in all PV subjects, with 3 of 4 subjects achieving B cell aplasia. Elevations in serum BAFF were observed, with 3 of 4 subjects achieving levels within the lowest end of the range exhibited in rese-cel treated AD subjects who received LD. Pathogenic PV autoantibodies decreased in 2 of 4 subjects. Together, these preliminary data suggest that LD may not be required for humanized CAR T efficacy in patients with AD.
Automated CAR T manufacturing using the Cellares Cell Shuttle Platform: Initial translational data from autoimmune subjects treated in RESET trials with rese-cel (Resecabtagene Autoleucel), an autologous 4-1BB CD19-CAR T cell therapy
May 14, 2026
CAR-T therapy without preconditioning in pemphigus vulgaris: Early clinical and translational data with resecabtagene autoleucel, an autologous 4-1BB CD19-CAR T
May 14, 2026
Single-cell profiling of PBMC subsets following rese-cel (ResecabtageneAutoleucel) treatment across the RESET- Myositis®, RESET-SScTM, and RESET-SLE trialsTM Phase 1 / 2 Cohorts
May 13, 2026
Consistency in resecabtagene autoleucel product quality across RESET phase 1/2 clinical trials and manufacturing platforms
May 12, 2026
RESET-MG: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB CD19-CAR T Cell Therapy in Generalized Myasthenia Gravis
April 20, 2026
RESET-Myositis: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB CD19-CAR T Cell Therapy in Idiopathic Inflammatory Myopathies
March 26, 2026
Myositis Disease & Treatment Landscape in the United States & Germany: Results from a Quantitative Physician Survey
March 25, 2026
CAR T Cell Therapy in Myositis: A Potential Emerging Treatment Option
March 23, 2026
RESET-SSc: Clinical Trial Evaluating Rese-cel in Systemic Sclerosis
Systemic Sclerosis World Congress | March 7, 2026
RESET-SLE: Clinical Trial Evaluating Rese-cel in Non-Renal SLE and LN
European Lupus Society | March 6, 2026
Mechanistic Basis of the Acute Safety Profile of Rese-cel in Patients with Autoimmune Disease in Four Ongoing Phase 1/2 Clinical Trials
ASH 2025 | December 6, 2025
RESET-MG: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB CD19-CAR T Cell Therapy in Generalized Myasthenia Gravis
AANEM 2025 | October 29, 2025
RESET-Myositis: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB CD19-CAR T Cell Therapy in Idiopathic Inflammatory Myopathies
ACR Convergence 2025 | October 29, 2025
Reprinted from ACR Convergence held 24-29 Oct 2025. The American College of Rheumatology does not guarantee, warrant, or endorse any commercial products or services. Reprinted by Cabaletta Bio.
CAR T Cell Therapy in Autoimmune Disease: A Potential Emerging Treatment Option
ACR Convergence 2025 | October 28, 2025
Reprinted from ACR Convergence held 24-29 Oct 2025. The American College of Rheumatology does not guarantee, warrant, or endorse any commercial products or services. Reprinted by Cabaletta Bio.
RESET-SLE: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), a Fully Human, Autologous 4-1BB CD19-CAR T Cell Therapy in Non-Renal SLE and Lupus Nephritis
ACR Convergence 2025 | October 28, 2025
Reprinted from ACR Convergence held 24-29 Oct 2025. The American College of Rheumatology does not guarantee, warrant, or endorse any commercial products or services. Reprinted by Cabaletta Bio.
RESET-SSc: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB CD19-CAR T Cell Therapy in Systemic Sclerosis
ACR Convergence 2025 | October 27, 2025
Reprinted from ACR Convergence held 24-29 Oct 2025. The American College of Rheumatology does not guarantee, warrant, or endorse any commercial products or services. Reprinted by Cabaletta Bio.
RESET-PV: Initial clinical and translational data evaluating rese-cel without preconditioning in pemphigus vulgaris
ESGCT 2025 | October 9, 2025
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of Rese-cel (CABA-201) in Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
CureJM Family Conference | June 27, 2025
RESET-SSc: Clinical Trial Evaluating Rese-cel (resecabtagene autoleucel), a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Systemic Sclerosis
EULAR 2025 | June 13, 2025
RESET-Myositis: Clinical Trial Evaluating Rese-cel (resecabtagene autoleucel), a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Idiopathic Inflammatory Myopathies
EULAR 2025 | June 13, 2025
RESET-SLE: Clinical Trial Evaluating Rese-cel (resecabtagene autoleucel), a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Non-renal SLE and Lupus Nephritis
EULAR 2025 | June 12, 2025
Clinical & Translational Findings Following Resecabtagene Autoleucel Anti-CD19 CAR T Cell Therapy in Autoimmune Disease
ASGCT 2025 | May 15, 2025
RESET-SSc™: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Systemic Sclerosis: Correlative Findings
ASGCT 2025 | May 14, 2025
RESET-SLE™: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Non-Renal SLE and Lupus Nephritis: Correlative Findings
ASGCT 2025 | May 14, 2025
RESET-MG: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19 Specific Chimeric Antigen Receptor T Cells (CABA-201) in Participants with Generalized Myasthenia Gravis
MGFA International Conference on Myasthenia and Related Disorders | May 13, 2025
Safety, efficacy, and correlative analyses of Rese-cel, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Myositis, Lupus, and Scleroderma from the RESET™ Clinical Trials
ICLE 2025 | February 22, 2025
Unleashing Immune Cells on Autoimmune Disease
2025 AAAS Annual Meeting | February 15, 2025
Achieving an immune system reset: The next act in CAR T therapy
ACR Convergence 2024 | November 18, 2024
Safety and efficacy of CABA-201, a fully human, autologous 4-1BB anti-CD19 CAR T cell therapy in patients with immune-mediated necrotizing myopathy and systemic lupus erythematosus from the RESET-Myositis™ and RESET-SLE™ clinical trials
ACR Convergence 2024 | November 17, 2024
Correlative Studies of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-Myositis™ and RESET-SLE™ Clinical Trials
ACR Convergence 2024 | November 16, 2024
Autologous CD19 CART manufacturing from whole blood collection for the treatment of autoimmune disease
ESGCT 2024 | October 24, 2024
Clinical and translational findings following MuSK-CAART infusion without preconditioning in patients with Myasthenia Gravis (MuSCAARTes™ trial)
ESGCT 2024 | October 24, 2024
Correlative findings following DSG3-CAART infusion with & without preconditioning in patients with Pemphigus Vulgaris (DesCAARTes™ trial)
ESGCT 2024 | October 22, 2024
Case study of CD19-directed chimeric antigen receptor T-cell therapy in a subject with immune-mediate necrotizing myopathy treated in the RESET-Myositis™ phase I/II trial
Molecular Therapy | September 7, 2024
Jenell Volkov, Daniel Nunez, Tahseen Mozaffar, Jason Stadanlick, Mallorie Werner, Zachary Vorndran, Alexandra Ellis, Jazmean Williams, Justin Cicarelli, Quynh Lam, Thomas Furmanak, Chris Schmitt, Fatemeh Hadi-Nezhad, Daniel Thompson, Claire Miller, Courtney Little, David Chang, Samik Basu
Under compassionate use, chimeric antigen receptor (CAR) T-cells have elicited durable remissions in patients with refractory idiopathic inflammatory myopathies (IIM)1. Here, we report on the safety, efficacy, and correlative data of the first subject with the immune-mediated necrotizing myopathy (IMNM) subtype of IIM who received a fully human, 4-1BBz anti-CD19-CAR T-cell therapy (CABA-201) in the RESET-Myositis™ phase I/II trial (NCT06154252). CABA-201 was well-tolerated following infusion. Notably, no evidence of cytokine release syndrome (CRS) or immune effector-cell associated neurotoxicity syndrome (ICANS) was observed. CK levels decreased, and muscular strength improved post-infusion. Peripheral B-cells were depleted rapidly following infusion, and the subject achieved peripheral B-cell aplasia by day 15 post-infusion. Peripheral B-cells returned at 2 months post-infusion and were almost entirely transitional. Autoantibodies to SRP-9, SRP-72, SRP-54, and Ro-52, decreased relative to baseline whereas antibodies associated with pathogens and vaccinations remained stable. The infusion product consisted of predominantly CD4+ effector memory T-cells & exhibited in vitro cytolytic activity. Post-infusion, CABA-201 expansion peaked at day 15 and was preceded by a serum IFN-γ peak on day 8 with peaks in serum IL-12p40 and IP-10 on day 15. These data detail the safety, efficacy, and pharmacodynamics of CABA-201 in the first IMNM subject.
Preclinical specificity and activity of a fully human 4-1BB expressing anti-CD19 CART therapy for treatment-resistant autoimmune disease
Molecular Therapy: Methods & Clinical Development | May 20, 2024
Binghao J. Peng, Andrea Alvarado, Hangameh Cassim, Soprina Guarneri, Steven Wong, Jonathan Willis, Julia SantaMaria, Ashley Martynchuk, Victoria Stratton, Darshil Patel, Chien-Chung Chen, Yan Li, Gwendolyn K. Binder, Rebecca Dryer-Minnerly, Jinmin Lee, Samik Basu
Over 4% of the global population is estimated to live with autoimmune disease, necessitating immunosuppressive treatment that is often chronic, not curative, and carries associated risks. B-cells have emerged as key players in disease pathogenesis, as evidenced by partial responsiveness to B-cell depletion by antibody-based therapies. However, these treatments often have transient effects due to incomplete depletion of tissue resident B-cells. Chimeric antigen receptor T (CART) cells targeting B-cells have demonstrated efficacy in refractory systemic lupus erythematosus. To this end, we developed an anti-CD19 CART product candidate, CABA-201, containing a clinically evaluated fully human CD19 binder (IC78) with a 4-1BB costimulatory domain and CD3 zeta stimulation domain for treatment refractory autoimmune disease. Here we demonstrate specific cytotoxic activity of CABA-201 against CD19+ Nalm6 cells with no off-target effects on primary human cells. Novel examination of CABA-201 generated from primary T-cells from multiple autoimmune disease patients displayed robust CAR surface expression and effective elimination of the intended target autologous CD19+ B-cells in vitro. Together, these findings support the tolerability and activity of CABA-201 for clinical development in patients with autoimmune disease.
Deep serological profiling of autoimmune patients treated with anti-CD19 4-1BBz CAR T-cells
ASGCT 2024 | May 9, 2024
Autologous CD19 CART manufacturing from whole blood collection for the treatment of autoimmune disease
ASGCT 2024 | May 9, 2024
Preclinical specificity and activity of CABA-201, a fully human 4-1BB containing CD19 CAR T therapy for treatment-resistant myositis
GCOM 2024 | March 15, 2024
Preclinical Specificity and Activity of CABA-201, a Fully Human 4-1BB Containing CD19 CAR T Therapy for Treatment-Resistant Autoimmune Disease
Tandem 2024 | February 22, 2024
Deep serological profiling of SLE patients treated with anti-CD19 4-1BBz CAR T-cells
ACR Convergence 2023 | November 13, 2023
Samik Basu, Daniel Nunez, Darshil Patel, Jenell Volkov, Zachary Vorndran, Steven Wong, Andreas Mackensen, Georg Schett.
Correlative findings following DSG3-CAART infusion with and without preconditioning in patients with Pemphigus Vulgaris (DesCAARTes™ study)
ESGCT | October 25, 2023
Cytokine and reactivity profiles in SLE patients following anti-CD19 CART therapy
Molecular Therapy: Methods & Clinical Development | September 1, 2023
Daniel Nunez, Darshil Patel, Jenell Volkov, Steven Wong, Zachary Vorndran, Fabian Müller, Michael Aigner, Simön Volkl, Andreas Mackensen, Georg Schett, Samik Basu
Chimeric antigen receptor (CAR) T cells targeting CD19+ B-cells have demonstrated efficacy in refractory systemic lupus erythematous (SLE). Although initial clinical data suggest that anti-CD19 CAR T-cell therapy is well tolerated and highly effective, the immunologic consequences of CAR T-cell therapy in SLE patients remain unclear. We profiled serum in six refractory SLE patients prior to and three months following CAR T-cell infusion. Three months post T-cell infusion, the inflammatory cytokines IL-6 and TNFα decreased in patient sera. This was accompanied by elevations in serum IL-7 and BAFF. Furthermore, SLE-associated antibodies dropped profoundly in five of six patients. Lastly, consistent with other reports of CD19 CAR T therapy in B-cell malignancies, we were able to show marginal impact of anti-CD19 CART therapy on pre-existing humoral immune responses in SLE patients. Together, these results provide insights into the mechanisms of efficacy of anti-CD19 CAR T-cell therapy in SLE.
Preclinical specificity and activity of CABA-201, a fully human 4-1BB containing CD19 CAR T therapy for treatment-resistant autoimmune disease
ASGCT 2023 | May 19, 2023
Correlative findings following DSG3-CAART infusion with and without combination preconditioning therapy in patients with PV (DesCAARTes study)
ASGCT 2023 | May 18, 2023
CAR T Cell to Treat Autoimmunity
ASGCT 2023 | May 16, 2023
Precision targeting of autoantigen-specific B cells in muscle-specific tyrosine kinase myasthenia gravis with chimeric autoantibody receptor T cells
Nature Biotechnology | January 19, 2023
Muscle-specifc tyrosine kinase myasthenia gravis (MuSK MG) is an autoimmune disease that causes life-threatening muscle weakness due to anti-MuSK autoantibodies that disrupt neuromuscular junction signaling. To avoid chronic immunosuppression from current therapies, we engineered T cells to express a MuSK chimeric autoantibody receptor with CD137-CD3ζ signaling domains (MuSK-CAART) for precision targeting of B cells expressing anti-MuSK autoantibodies. MuSK-CAART demonstrated similar efcacy as anti-CD19 chimeric antigen receptor T cells for depletion of anti-MuSK B cells and retained cytolytic activity in the presence of soluble anti-MuSK antibodies. In an experimental autoimmune MG mouse model, MuSK-CAART reduced anti-MuSK IgG without decreasing B cells or total IgG levels, refecting MuSK-specifc B cell depletion. Specifc of-target interactions of MuSK-CAART were not identifed in vivo, in primary human cell screens or by high-throughput human membrane proteome array.These data contributed to an investigational new drug application and phase 1 clinical study design for MuSK-CAART for the treatment of MuSK autoantibody-positive MG.
Characterization of DSG3-CAART cells prior to & following adoptive transfer in mPV
ESGCT Congress | October 13, 2022
A Phase 1 trial of DSG3-CAART cells in mucosal-dominant pemphigus vulgaris patients: preliminary data
EADV Congress | September 10, 2022
A Phase 1 trial of DSG3-CAART cells in mucosal-dominant pemphigus vulgaris patients: preliminary data
EADV Congress (Abstract Only) | August 29, 2022
A Phase 1 Trial Of DSG3-CAART Cells In mPV Patients: Early Cohort Clinical and Translational Data
SID 2022 | May 20, 2022
Characterization of DSG3-CAART Cells Prior To & Following Adoptive Transfer in mPV
ASGCT 2022 | May 17, 2022
A Phase 1 Trial of Targeted DSG3-CAART Cell Therapy in mPV Patients: Early Cohort Data
ASGCT 2022 | May 17, 2022
Chimeric autoantibody receptor (CAAR) T cells as a precision therapy for antigen-specific B cell depletion in PLA2R membranous nephropathy
ASN Kidney Week 2021 | November 5, 2021
Antigen-specific B-cell depletion for precision therapy of mucosal pemphigus vulgaris
The Journal of Clinical Investigation | August 20, 2020
Desmoglein 3 chimeric autoantibody receptor T cells (DSG3-CAART) expressing the pemphigus vulgaris (PV) autoantigen DSG3 fused to CD137-CD3ζ signaling domains, represent a precision cellular immunotherapy approach for antigen-specific B cell depletion. Here, we present definitive preclinical studies enabling a first-in-human trial of DSG3-CAART for mucosal PV. DSG3-CAART specifically lysed human anti-DSG3 B cells from PV patients and demonstrated activity consistent with a threshold dose in vivo, resulting in decreased target cell burden, decreased serum and tissue-bound autoantibodies, and increased DSG3-CAART engraftment.
MuSK chimeric autoantibody receptor (CAAR) T cells for antigen-specific cellular immunotherapy of myasthenia gravis
AAN 2020 Abstract 2769 | May 18, 2020
Reengineering chimeric antigen receptor T cells for targeted therapy of autoimmune disease
Science | July 8, 2016
Autoimmune diseases such as lupus and rheumatoid arthritis lack therapies that specifically target only the disease-causing cells. Inspired by the clinical success of using chimeric antigen receptor T cells to treat certain types of cancers, Ellebrecht et al. asked whether a similar approach might also work against antibody-driven autoimmune diseases.