resecabtagene autoleucel (CABA-201)
/ Cabaletta Bio, IASO BIO
- LARVOL DELTA
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March 30, 2025
RESET-SScTM: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Systemic Sclerosis
(EULAR 2025)
- P1/2 | "A single weight-based infusion of 1x10 6 CAR T cells/kg is administered following a preconditioning regimen (fludarabine 25 mg/m 2 /d on Days -5, -4 and -3, and cyclophosphamide 1,000 mg/m 2 on Day -3)...The patient experienced grade 2 cytokine release syndrome (CRS), manifesting as fever and hypotension which resolved following intravenous fluids without requiring tocilizumab... Data from the first SSc patient with significant skin involvement and disability dosed with rese-cel demonstrates early immunosuppressive-free clinical response and favorable safety profile in the setting of CAR T cell expansion and complete peripheral and lymph node B-cell depletion. These initial data suggest the potential for rese-cel to reset the immune system in SSc, allowing patients to achieve meaningful clinical responses while off all immunosuppressive therapies. Additional patients undergoing rese-cel infusion in early 2025 will be presented at the EULAR meeting."
CAR T-Cell Therapy • Clinical • Cardiovascular • Hypotension • Immunology • Inflammation • Rheumatology • Scleroderma • Systemic Sclerosis • CD20 • CD24 • CD38 • CD8 • IFNG • IL6
March 30, 2025
RESET-MyositisTM: 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)
- P1/2 | "A single weight-based infusion of 1x10 6 CAR T cells/kg is administered following a preconditioning regimen (fludarabine 25 mg/m 2 /d on Days -5, -4 and -3, and cyclophosphamide 1,000 mg/m 2 on Day -3). Data from IIM patients dosed with rese-cel demonstrate early immunomodulatory-free clinical responses and a favorable safety profile in the setting of CAR T cell expansion and peripheral B cell depletion. These initial data suggest the potential for rese-cel to reset the immune system in IIM, allowing patients to achieve meaningful clinical responses while off all immunomodulatory therapies and tapering glucocorticoids."
CAR T-Cell Therapy • Clinical • Cardiovascular • Dermatomyositis • Immunology • Myositis • Pulmonary Embolism • Rare Diseases • Respiratory Diseases • CD8 • IFNG
March 30, 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)
- P1/2 | "A single weight-based infusion of 1x10 6 CAR T cells/kg is administered following a preconditioning regimen (fludarabine 25 mg/m 2 /d on Days -5, -4 and -3, and cyclophosphamide 1,000 mg/m 2 on Day -3)...Rese-cel has been well-tolerated with Grade 1 cytokine release syndrome (CRS) (fever) reported in 2 patients, SLE-2 and LN-1, neither of whom received tocilizumab...All patients remain off all SLE-related immunosuppression, and SLE-1 and SLE-2 have completed their glucocorticoid taper, while LN-1 has tapered to prednisone 6 mg/day as of the most recent follow-up visit... Data from SLE patients dosed with rese-cel demonstrate early immunosuppressive-free clinical remission and/or responses and favorable safety profile, including CRS events, in the setting of CAR T cell expansion and peripheral B-cell depletion. These initial data suggest the potential for rese-cel to reset the immune system in SLE, allowing patients to achieve meaningful clinical responses while..."
CAR T-Cell Therapy • Clinical • Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • CD4 • CD8 • IFNG
June 11, 2025
Cabaletta Bio Announces New Rese-cel Safety and Efficacy Data in Patients with…Lupus…to Be Presented at the EULAR 2025 Congress
(GlobeNewswire)
- P1/2 | N=12 | RESET-SLE (NCT06121297) | Sponsor: Cabaletta Bio | "7 out of 7 patients achieved a clinical response off all immunomodulators and glucocorticoids. All non-renal systemic lupus erythematosus (SLE) patients without nephropathy achieved DORIS as of the latest follow-up. The first lupus nephritis (LN) patient achieved DORIS and a complete renal response, while follow-up is continuing on the other two LN patients who were treated more recently. In the 8 patients with safety follow-up, 2 of 8 experienced grade 1 CRS (fever) and 1 ICANS event was observed (grade 4, previously reported)."
P1/2 data • Systemic Lupus Erythematosus
June 11, 2025
Cabaletta Bio Announces New Rese-cel Safety and Efficacy Data in Patients with…Scleroderma to Be Presented at the EULAR 2025 Congress
(GlobeNewswire)
- P1/2 | N=12 | RESET-SSc (NCT06328777) | Sponsor: Cabaletta Bio | "Both of the patients reported in the severe skin cohort had meaningful modified Rodnan Skin Score (mRSS) improvements after discontinuing immunomodulatory drugs and steroids, which was sustained out to 6 months in the first patient. The first patient also met the revised Composite Response Index in Systemic Sclerosis (CRISS) criteria starting at 3 months, highlighting the potential of rese-cel to provide a drug-free, clinical response in patients with systemic sclerosis (SSc). One patient experienced transient grade 2 CRS and one ICANS event was observed (grade 3, previously reported)."
P1/2 data • Scleroderma • Systemic Sclerosis
June 11, 2025
Cabaletta Bio Announces New Rese-cel Safety and Efficacy Data in Patients with Myositis…to Be Presented at the EULAR 2025 Congress
(GlobeNewswire)
- P1/2 | N=24 | RESET-Myositis (NCT06154252) | Sponsor: Cabaletta Bio | "7 out of 8 patients achieved a clinical response off all immunomodulators, while off or actively tapering steroids. All 4 antisynthetase syndrome (ASyS) and dermatomyositis (DM) patients achieved a clinically meaningful total improvement score (TIS) response, with 3 of these patients having achieved a major TIS response as of the data cut-off date. Clinically meaningful drug-free responses were observed in 3 of 4 refractory patients with immune-mediated necrotizing myopathy (IMNM), which are consistent with published data. These findings continue to reflect the more modest TIS responses in IMNM compared to other myositis subtypes. Regarding safety, 4 of 8 patients experienced grade 1 CRS (fever), and no ICANS was observed."
P1/2 data • Immunology • Myositis
June 11, 2025
Rese-cel Translational Profile
(GlobeNewswire)
- P=NA| N=NA | "Peak rese-cel expansion was observed within approximately two weeks. B cells were rapidly and transiently reduced in peripheral blood within the first month and their repopulation was observed beginning approximately two months after infusion, generally expressing a transitional, naïve phenotype. Tissue-resident B cell depletion was confirmed via a lymph node biopsy in the first systemic sclerosis patient."
Clinical data • Systemic Sclerosis
June 05, 2025
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
(clinicaltrials.gov)
- P1/2 | N=12 | Not yet recruiting | Sponsor: Cabaletta Bio
New P1/2 trial • CNS Disorders • Multiple Sclerosis
April 10, 2025
RESET-MyositisTM: Clinical Trial Evaluating Rese-cel (Resecabtagene Autoleucel), A Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Idiopathic Inflammatory Myopathies: Correlative Findings
(ASGCT 2025)
- P1/2 | "Leukocyte and lymphocyte counts dropped quickly and transiently after a standard preconditioning regimen of fludarabine (25mg/m2/day x 3) and cyclophosphamide (1000mg/m2) which inversely corresponded with a transient elevations in serum IL-15 levels in all patients. These emerging data detail the pharmacokinetics and pharmacodynamics of rese-cel in adult patients with IIM, supporting the potential for rese-cel to induce durable, drug-free remissions. Evaluation of the safety and efficacy of rese-cel continues in the ongoing Phase 1/2 RESET-MyositisTM trial. Disease Focus of Abstract:Autoimmune Disorders"
CAR T-Cell Therapy • Clinical • Dermatomyositis • Immunology • Infectious Disease • Myositis • Rare Diseases • CD20 • CD24 • CD8 • IFNG • IL15 • SAE1 • SRP54
April 10, 2025
RESET-SSc TM : 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)
- P1/2 | "The patient experienced grade 2 cytokine release syndrome (CRS), manifesting as fever and hypotension which resolved following intravenous fluids without requiring tocilizumab...Leukocyte and lymphocyte counts dropped quickly and transiently after a standard preconditioning regimen of fludarabine (25 mg/m2/day x 3) and cyclophosphamide (1000 mg/m2) which inversely corresponded with an elevation in serum IL-15 levels... These emerging data detail the pharmacokinetics and pharmacodynamics of rese-cel in one SSc patient. Rese-cel deeply and transiently depleted B cells in circulation and in lymphoid tissue and support the potential for rese-cel to induce durable, drug-free remission. Evaluation of the safety and efficacy of rese-cel continues in the ongoing Phase 1/2 RESET-SScTM trial."
CAR T-Cell Therapy • Clinical • Hypotension • Immunology • Inflammation • Scleroderma • Systemic Sclerosis • CD20 • CD24 • CD8 • IFNG • IL15 • IL6
April 10, 2025
RESET-SLE TM : 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)
- P1/2 | "Leukocyte and lymphocyte counts reduced quickly and transiently after a standard preconditioning regimen of fludarabine (25mg/m2/day x 3) and cyclophosphamide (1000mg/m2) that inversely corresponded with a transient elevation in serum IL-15 levels. These emerging data detail the pharmacokinetics and pharmacodynamics of rese-cel in patients with SLE and LN and support the potential for rese-cel to lead to durable, drug-free remissions. Evaluation of safety and efficacy of rese-cel continues in the ongoing Phase 1/2 RESET-SLETM trial. Disease Focus of Abstract:Autoimmune Disorders"
CAR T-Cell Therapy • Clinical • Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • CD20 • CD24 • CD8 • IFNG • IL15
March 23, 2025
Clinical & Translational Findings Following Resecabtagene Autoleucel Anti-CD19 CAR T Cell Therapy in Autoimmune Disease
(ASGCT 2025)
- "Supported by the Hematologic and Immunologic Cell and Gene Therapy Committee Info Description: An overview of the translational data in subjects dosed with rese-cel (Resecabtagene Autoleucel) autologous anti-CD19 CAR T cell therapy in autoimmune disease."
CAR T-Cell Therapy • Clinical • Gene Therapies • Immunology
May 15, 2025
Cabaletta Bio Announces 2027 Rese-cel BLA Submission Anticipated in Myositis Following Recent FDA Alignment on Registrational Cohorts
(GlobeNewswire)
- "New clinical data from each of the RESET-Myositis, RESET-SLE and RESET-SSc trials will be presented in three oral presentations at the upcoming EULAR 2025 Congress from June 11-14, 2025, in Barcelona, Spain."
P1/2 data • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis
May 15, 2025
Cabaletta Bio Announces 2027 Rese-cel BLA Submission Anticipated in Myositis Following Recent FDA Alignment on Registrational Cohorts
(GlobeNewswire)
- "SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25...Cabaletta Bio, Inc...announced plans for an anticipated 2027 rese-cel BLA submission following a recent U.S. Food and Drug Administration (FDA) meeting on a proposed registrational cohort design for the RESET-Myositis trial of rese-cel...Following a Type C meeting with the FDA and receipt of meeting minutes in April 2025, Cabaletta is planning to implement the following design for two single-arm, disease-specific registrational cohorts in the ongoing RESET-Myositis trial, either of which, if successful, enable a future Biologics License Application (BLA) submission for rese-cel in myositis: One cohort will evaluate approximately 15 patients with either dermatomyositis (DM) or antisynthetase syndrome (ASyS) and one cohort will evaluate approximately 15 patients with immune-mediated necrotizing myopathy (IMNM)."
FDA event • FDA filing • Trial status • Lupus Nephritis • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis
April 01, 2025
Study of CAR T-cell therapy rese-cel in scleroderma enrolling in US
(Scleroderma News)
- "A Phase 1/2 trial testing Cabaletta Bio’s CAR T-cell therapy, rese-cel (resecabtagene autoleucel), in adults with hard-to-treat systemic sclerosis (SSc) is recruiting patients at several sites in the U.S. The open-label RESET-SSc trial (NCT06328777) is assessing the safety and efficacy of rese-cel as a single infusion into a vein, or intravenously, in patients ages 18-75. It plans to enroll two groups of patients, one with severe skin involvement and the other with heart, lung, and/or kidney involvement, with or without skin manifestations."
Enrollment status • Systemic Sclerosis
March 31, 2025
Cabaletta Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
(GlobeNewswire)
- "In June 2025, Cabaletta plans to present new and updated clinical and translational data on rese-cel from the RESET-Myositis, RESET-SLE and RESET-SSc trials in three oral presentations at the upcoming EULAR 2025 Congress, which is being held at Fira de Barcelona in Barcelona, Spain from June 11-14, 2025."
P1/2 data • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis
March 19, 2025
Cellares and Cabaletta Bio Successfully Complete Manufacturing Technology Adoption Program for Rese-cel Using the Cell Shuttle Platform
(Businesswire)
- "Cellares...has concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle for resecabtagene autoleucel...Rese-cel is the lead clinical candidate in development by Cabaletta Bio...This successful collaboration facilitates the opportunity to engage in a clinical and commercial manufacturing relationship. Cellares’ TAP assessed the feasibility of using Cellares' innovative Cell Shuttle platform to automate the manufacturing of Cabaletta's rese-cel drug product, a CD19-targeting CAR T cell therapy designed to treat patients with a broad range of autoimmune diseases."
Commercial • Immunology
February 18, 2025
Cabaletta Bio Announces Updated Clinical Data Demonstrating Deepening Clinical Responses across Multiple Indications with Rese-cel at February Scientific Meetings
(GlobeNewswire)
- P1/2 | N=24 | RESET-Myositis (NCT06154252) | P1/2 | N=12 | RESET-SLE (NCT06121297) | P1/2 | N=12 | RESET-SSc (NCT06328777) | Sponsor: Cabaletta Bio | "As of the data cut-off date of January 8, 2025, 10 patients had been dosed with rese-cel across the RESET-Myositis, RESET-SLE and RESET-SSc trials...In the RESET-Myositis trial, the first adult dermatomyositis patient maintained a major total improvement score (TIS) improvement at 3 months post-infusion; In the RESET-SLE trial, 3 out of 4 patients in the non-renal systemic lupus erythematosus (SLE) cohort achieved DORIS (definition of remission in SLE) remission; In the RESET-SSc trial, the first patient dosed with rese-cel in the severe skin cohort continued to demonstrate clinically meaningful skin improvements; Across the first 10 patients dosed with rese-cel with at least one month of follow-up, 90% experienced either no cytokine release syndrome (CRS) or grade 1 CRS (fever)..."
P1/2 data • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis
February 11, 2025
Cabaletta Bio Announces Presentations Featuring Updated Clinical Data on Rese-cel at Upcoming Scientific Meetings in February
(GlobeNewswire)
- "Cabaletta Bio, Inc...announced that updated clinical data on resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) will be featured in presentations at the 2025 American Association for the Advancement of Science Annual Meeting, which is being held at the Hynes Convention Center in Boston, MA from February 13-15, 2025, and the 5th International Conference on Lymphocyte Engineering, which is being held at the Holiday Inn Munich – City Center in Munich, Germany from February 20-22, 2025. The presentations will include safety, translational data and clinical outcomes from the first 10 patients dosed with rese-cel across multiple ongoing clinical trials in the RESET clinical development program."
P1/2 data • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis
January 13, 2025
Cabaletta Bio Outlines Strategic Priorities and Anticipated Key Milestones for 2025
(GlobeNewswire)
- "The first patient has been enrolled in the RESET-PV trial, evaluating rese-cel without preconditioning in patients with pemphigus vulgaris. The first juvenile myositis clinical site in the RESET-Myositis trial is now open and actively recruiting. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Disease designation for rese-cel in juvenile dermatomyositis. The first patient has been enrolled in the RESET-MG trial, evaluating rese-cel in patients with myasthenia gravis.The Investigational New Drug (IND) application for rese-cel has been allowed to proceed within the routine 30-day window by the FDA for the RESET-MS trial...The Company now plans to meet with the FDA regarding registrational trial designs for rese-cel in the first half of 2025 based on the emerging clinical and translational data and increased pace of enrollment...Present new and updated clinical and translational data on rese-cel throughout 2025."
Clinical data • Enrollment open • FDA event • IND • Trial status • Dermatomyositis • Multiple Sclerosis • Myasthenia Gravis • Pemphigus Vulgaris
December 27, 2024
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
(clinicaltrials.gov)
- P1/2 | N=24 | Recruiting | Sponsor: Cabaletta Bio | N=18 ➔ 24
Enrollment change • Dermatomyositis • Immunology • Myositis • Rare Diseases
September 25, 2024
220: Achieving an Immune System RESET: The Next Act in CAR T Therapy
(ACR Convergence 2024)
- "Sponsored by Cabaletta Bio...Speakers will also provide an overview of the distinguishing features of CABA-201, a CD19-CAR T cell therapy candidate, and the RESET™ Ph 1/2 clinical program in several autoimmune diseases, including lupus, myositis, and systemic sclerosis. Not an official program of the ACR. Non-CME"
Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Sclerosis
September 25, 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-MyositisTM and RESET-SLETM Clinical Trials
(ACR Convergence 2024)
- P1/2 | "Leukocyte and lymphocyte counts dropped quickly and transiently after a standard preconditioning regimen of fludarabine (25mg/m2/dy x 3) and cyclophosphamide (1000mg/m2) which inversely corresponded with a transient peak in serum IL-15 levels in both patients. These emerging data detail the pharmacokinetics and pharmacodynamics of CABA-201 in IIM and SLE. Evaluation of the selected CABA-201 dose continues in the ongoing RESET-Myositis and RESET-SLE trials."
CAR T-Cell Therapy • Clinical • Dermatomyositis • Glomerulonephritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Rare Diseases • Systemic Lupus Erythematosus • IFNG • IL15
September 25, 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-MyositisTM and RESET-SLETM Clinical Trials
(ACR Convergence 2024)
- P1/2 | "For both trials, a single infusion of 1×106 CAR T cells/kg is administered following a preconditioning regimen of cyclophosphamide and fludarabine...At 3 months post infusion, the IMNM subject achieved a meaningful response in the total improvement score, associated with improvements in the CK to 308 and MMT-8 to 134, as well as reduction in anti-SRP and anti-Ro52 levels, while off methotrexate and glucocorticoids. At 1 month post infusion, the SLE subject achieved a SLEDAI-2K improvement of 16 points with resolution of vasculitis, arthritis, and hematuria and reduction in the anti-dsDNA titer, while off mycophenolate and hydroxychloroquine and on a prednisone taper.Safety outcomes are in Table 2. Both subjects tolerated CABA-201 treatment with no SAE, CRS, or ICANS... Both subjects tolerated CABA-201 treatment with no SAE, CRS, or ICANS. The administered dose of CABA-201 resulted in CAR T cell expansion, peripheral B cell depletion, and biomarker and..."
CAR T-Cell Therapy • Clinical • Dermatomyositis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Pediatrics • Rare Diseases • Rheumatology • Systemic Lupus Erythematosus • Vasculitis
November 18, 2024
Cabaletta Bio Presents Positive Clinical Safety and Efficacy Data on CABA-201 at ACR Convergence 2024
(GlobeNewswire)
- P1/2| N=18 | RESET-Myositis (NCT06154252) | P1/2| N=18 | RESET-SLE (NCT06121297) | P1/2| N=18 | RESET-SSc (NCT06328777)| Sponsor: Cabaletta Bio | "Cabaletta Bio...today announced new and updated clinical data on CABA-201 demonstrating the potential to achieve drug-free, compelling clinical responses based on eight patients dosed across the ongoing Phase 1/2 RESET-Myositis, RESET-SLE and RESET-SSc clinical trials....As of the data cut-off date of November 1, 2024, eight patients had been dosed with CABA-201 with sufficient follow-up to be evaluable across the RESET clinical development program....Across these eight patients treated with CABA-201, patients were administered a one-time infusion of CABA-201 at 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. The primary endpoint of each trial is safety and tolerability within 28 days of infusion."
P1/2 data • Myositis • Systemic Lupus Erythematosus • Systemic Sclerosis
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