Descartes-08 / Cartesian Therapeutics - LARVOL DELTA

Safety and clinical activity of autologous RNA chimeric antigen receptor T-cell therapy in myasthenia gravis (MG-001): a prospective, multicentre, open-label, non-randomised phase 1b/2a study. (PubMed, Lancet Neurol) - P2 | "In this first study of an rCAR-T therapy in individuals with an autoimmune disease, Descartes-08 appeared to be safe and was well tolerated. Descartes-08 infusions were followed by clinically meaningful decreases on myasthenia gravis severity scales at up to 9 months of follow-up. rCAR-T therapy warrants further investigation as a potential new treatment approach for individuals with myasthenia gravis and other autoimmune diseases."

CAR T-Cell Therapy • IO biomarker • Journal • P1/2 data • P2 data • Cardiovascular • CNS Disorders • Hematological Disorders • Hematological Malignancies • Immunology • Myasthenia Gravis • Oncology • Pain • IL2 • IL6

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis (clinicaltrials.gov) - P3 | N=128 | Active, not recruiting | Sponsor: Cartesian Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Immunology • Myasthenia Gravis

Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG) (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Cartesian Therapeutics | Trial completion date: Mar 2026 ➔ Sep 2026 | Trial primary completion date: Jul 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • CNS Disorders • Immunology • Myasthenia Gravis

Cartesian has partnered with WestGene to conduct a Phase 1 dose-escalation trial of the mRNA used in Descartes-08 delivered via WestGene’s proprietary targeted lipid nanoparticles (tLNPs) in patients with MG (GlobeNewswire) - "This clinical trial is expected to initiate in the second half of 2026 with in-human data expected in the first half of 2027."

New P1 trial • P1 data • Immunology • Myasthenia Gravis

Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Autoimmune Diseases, Including JDM, Continues to Progress with Data Expected in 1H27 (GlobeNewswire) - "Enrollment remains ongoing in the Phase 1/2 HELIOS pediatric trial of Descartes-08 in children and young adults with autoimmune diseases, including JDM."

P1/2 data • Trial status • Dermatomyositis • Immunology

Phase 2 TRITON Trial in Myositis Remains on Track with Data from Subset of Patients Expected in 1H27 to Inform Path Forward to Pivotal Trial (GlobeNewswire) - "The randomized, double-blind, placebo-controlled Phase 2 TRITON trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is to assess the safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis. The Company plans to evaluate a subset of patients from the trial to determine the potential path to a pivotal trial in myositis."

P2 data • Trial status • Dermatomyositis • Immunology

Phase 3 AURORA Trial of Descartes-08 in Participants with MG; Data Expected in 1Q27, with BLA Planned for Mid-2027 (GlobeNewswire) - "The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08, Cartesian’s autologous anti-B cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo."

FDA filing • P3 data • Myasthenia Gravis

Cartesian Therapeutics Announces Strategic Licensing Agreement with WestGene Biopharma to Accelerate the Development of In Vivo CAR-T Platform in Autoimmune Diseases (GlobeNewswire) - "Cartesian is partnering with WestGene to conduct a Phase 1 dose-escalation study of the mRNA used in Descartes-08 delivered via WestGene’s proprietary targeted lipid nanoparticles (tLNPs) in patients with generalized myasthenia gravis...In addition to Descartes-08, Cartesian’s tested CAR construct with the potential to be evaluated initially with the WestGene LNP delivery platform, Cartesian is also planning to advance multiple internally developed next-generation anti-BCMA CAR constructs and a BCMA-directed T-cell engager (TCE) as part of its expanding mRNA payload portfolio....Under the terms of the agreement, WestGene will receive an upfront payment and is eligible to receive potential development and commercial based milestone payments. This clinical study is expected to initiate in 2H 2026 with in-human data expected in 1H 2027."

Licensing / partnership • New P1 trial • P1 data • Immunology • Myasthenia Gravis

Cartesian Therapeutics Secures up to $150 Million of Non-Dilutive Financing from K2 HealthVentures and Expects Topline Data from the Phase 3 AURORA Trial in First Quarter 2027 (GlobeNewswire) - "Topline data from Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 1Q27; BLA filing planned for mid-2027; Data from subset of patients in Phase 2 TRITON trial of Descartes-08 in myositis expected in 1H27; Data from Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis expected in 1H27."

FDA filing • Financing • P1/2 data • P2 data • P3 data: top line • Dermatomyositis • Immunology • Myasthenia Gravis • Myositis

Beyond Conventional CAR-T: Implementing mRNA CAR-T Therapy for Myasthenia Gravis Across Academic and Community Settings (ASGCT 2026) - "Descartes-08 is an autologous mRNA CAR-T cell therapy directed towards B-cell maturation antigen (BCMA) expressing cells such as plasma cells and plasmacytoid dendritic cells, both of which have been implicated in the immunopathogenesis of autoimmune disease...mRNA CAR-T, which is transient and does not integrate via viral vectors, may present a reduced risk profile for developing lymphoproliferative disorders. Long-term follow-up data is currently unavailable."

CAR T-Cell Therapy • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Myasthenia Gravis • Myositis

Scalable manufacturing and immune phenotype characterization of BCMA-directed mRNA CAR T-cell therapy for myasthenia gravis (ASGCT 2026) - "The presence of memory and stem-like T-cell subsets, together with minimal exhaustion marker expression, suggests a CAR T-cell product with durable and potent immunomodulatory effects. These results support the feasibility of scalable production of Descartes-08 and achievement of reproducible immune phenotypes across diverse patient populations, advancing the potential accessibility and therapeutic application of mRNA CAR T- cell therapy for autoimmune disease in an outpatient setting."

CAR T-Cell Therapy • IO biomarker • CNS Disorders • Immunology • Inflammation • Myasthenia Gravis • CD8 • ENTPD1 • LAG3

Refining BCMA-directed CAR-T cell pharmacokinetics through RNA format optimization (ASGCT 2026) - "For example, Descartes-08 BCMA CAR-T cells have produced durable reductions in symptom burden in patients with myasthenia gravis...Conclusion Collectively, these findings highlight the value of RNA format optimization for engineering transient CAR-T cells with superior pharmacokinetic and therapeutic profiles. Beyond circular RNA, we are also investigating other alternative RNA formats, several of which are yielding highly promising results."

CAR T-Cell Therapy • IO biomarker • PK/PD data • CNS Disorders • Immunology • Myasthenia Gravis

Pipeline Progress and Anticipated Milestones (GlobeNewswire) - "Enrollment Continues to Progress in the Phase 3 AURORA Trial of Descartes-08 in Participants with MG....Multiple Patients Enrolled in Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Autoimmune Diseases, Including JDM."

Enrollment status • Dermatomyositis • Immunology • Myasthenia Gravis

Post-hoc Analysis of Descartes-08, BCMA-directed mRNA CAR-T Therapy, in Biologic Non-responsive Versus Biologic Naive Generalized Myasthenia Gravis: Results from a Phase 2b Randomized Trial (AAN 2026) - "Conclusions Both biologic non-responders and the biologic naive participants had greater improvement in MG efficacy measures after Descartes-08 compared to placebo, with greater depth of response in the biologic naive group. Changes in key cytokines may underpin the differential response."

CAR T-Cell Therapy • Clinical • IO biomarker • P2b data • Retrospective data • CNS Disorders • Hematological Disorders • Infectious Disease • Myasthenia Gravis

Descartes-08: Unlocking the potential of mRNA CAR T-cell therapy in myasthenia gravis. (PubMed, Mol Ther) - No abstract available

Journal • CNS Disorders • Myasthenia Gravis

Descartes-08 in Autoantibody Myositis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Cartesian Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ May 2028 | Trial primary completion date: Nov 2026 ➔ Nov 2027

Enrollment open • Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis • Rare Diseases

Descartes-08 in Autoantibody Myositis (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Cartesian Therapeutics | Initiation date: Mar 2026 ➔ Jun 2026

Trial initiation date • Dermatomyositis • Immunology • Myositis • Rare Diseases

SLE-001: Descartes-08 for Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=6 | Active, not recruiting | Sponsor: Cartesian Therapeutics | Trial completion date: Nov 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Cartesian Therapeutics | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • ANCA Vasculitis • CNS Disorders • Dermatomyositis • Immunology • Inflammatory Arthritis • Lupus • Myasthenia Gravis • Myositis • Systemic Lupus Erythematosus • Vasculitis

Pipeline Progress and Anticipated Milestones (The Manila Times) - "Enrollment Continues to Progress in the Phase 3 AURORA Trial of Descartes-08 in Participants with MG...Phase 2 TRITON Trial Initiation in Myositis Anticipated in 1H26...The Company currently intends to conduct a blinded interim analysis through the Data Safety Monitoring Board (DSMB) after ten patients reach the primary endpoint, at which point Cartesian may revise sample size assumptions to what could be necessary to support the trial becoming pivotal, pending FDA review....Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Juvenile Dermatomyositis (JDM) Remains Ongoing."

Trial status • Dermatomyositis • Immunology • Myasthenia Gravis • Myositis

MDA 2026: CAR T-cell therapy Descartes-08 eases MG symptoms (Myasthenia Gravis News) - "Newly presented data concerned the subgroup of 19 evaluable participants who were positive for anti-AChR antibodies. Of the 11 patients treated with Descartes-08, seven (63%) achieved a 5-point drop in MCG score within three months. By contrast, only one of the eight patients given the placebo (12.5%) met that outcome. This difference was statistically significant....Mozaffar noted that more stringent cutoffs showed even greater differences. About a third of patients given Descartes-08 (36.4%) showed an MCG score reduction of at least 6 points, and more than a third (27.3%) experienced a score drop of 7 or more points, while no participants in the placebo group experienced such improvements."

P2b data • Immunology • Myasthenia Gravis

Descartes-08 in Autoantibody Myositis (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Cartesian Therapeutics

New P2 trial • Dermatomyositis • Immunology • Myositis • Rare Diseases

Today, the Company announced the publication of two peer-reviewed journal articles in Nature Medicine detailing the mechanism of action of Descartes-08 as well as reiterating data surrounding the Phase 2b trial of Descartes-08 in patients with MG. (GlobeNewswire) - "Data illustrated within the mechanism of action article observed that transient targeting of BCMA with Descartes-08 achieved precision retuning of autoreactivity in MG....the Phase 2b trial of Descartes-08 in patients with MG, the second publication outlines deep and durable responses observed through 12 months after a single course of therapy. Deepest and most compelling sustained responses were observed in patients without prior biologic therapies (n=7) with 57% of these participants achieving minimal symptom expression by Month 6 and maintaining it through Month 12....the Company also reported that after beginning medication tapering at Month 6 follow-up, the median reduction in prednisone daily dose was 55% at Month 12."

P2b data • Myasthenia Gravis

Beyond myositis in adult indications, Cartesian today announced the initiation of its Phase 1/2 (HELIOS) pediatric trial of Descartes-08 in children and young adults with autoimmune diseases, including juvenile dermatomyositis (JDM), a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems. (GlobeNewswire)

Trial status • ANCA Vasculitis • Dermatomyositis • Myasthenia Gravis • Systemic Lupus Erythematosus

Descartes-08 Program Updates (GlobeNewswire) - "The Company plans to initiate this Phase 2 seamless adaptive clinical trial, which offers a potential opportunity for a single pivotal trial in the first half of 2026. The randomized, double-blind, placebo-controlled Phase 2 trial in myositis (TRITON) is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in up to 50 participants with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome."

New P2 trial • Dermatomyositis • Myositis