---
title: "CD19 CAR T-cell therapy (mivocabtagene autoleucel) in refractory seropositive rheumatoid arthritis"
id: "nature-1-cd19-car-t-cell-therapy-for-treatment-refractory-seropositive-rheumatoid"
canonical_url: "https://medichelpline.com/clinical-feed/nature-1-cd19-car-t-cell-therapy-for-treatment-refractory-seropositive-rheumatoid"
content_type: "clinical_feed_article"
specialty: "Rheumatology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04603-3"
published_at: "2026-08-27T09:55:43.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# CD19 CAR T-cell therapy (mivocabtagene autoleucel) in refractory seropositive rheumatoid arthritis
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-1-cd19-car-t-cell-therapy-for-treatment-refractory-seropositive-rheumatoid
- **Specialty:** [Rheumatology](https://medichelpline.com/clinical-feed/rheumatology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04603-3)
- **Published At:** 2026-08-27T09:55:43.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- This report presents the phase 1 portion of the COMPARE trial testing autologous fully human **CD19 CAR T cell** therapy, mivocabtagene autoleucel (**miv-cel**), in treatment-refractory, seropositive rheumatoid arthritis (RA). - Six patients (three men, three women) with severe, treatment-refractory, anti-citrullinated protein antibody (**ACPA**)-positive RA received a single infusion of miv-cel after stopping all disease-modifying antirheumatic drugs and standard lymphodepletion. - Patients were followed for 36–52 weeks for safety and efficacy; primary endpoints were incidence and severity of **cytokine release syndrome (CRS)**, immune effector cell-associated neurotoxicity syndrome (ICANS) and adverse events (AEs) within 4 weeks post-treatment. - **CRS** occurred in all six patients but was limited to grade 1–2 events. No ICANS or serious AEs were reported during the primary safety window. - One dose-limiting toxicity (DLT) occurred: a grade 3 transaminase elevation that resolved without sequelae. - CAR T cell infusion produced depletion of **CD19+ B cells** in blood and tissue and a continuous decline in autoantibody titers. - Seroconversion was observed for autoantibodies in several patients: four of six for ACPAs against mutated citrullinated vimentin and five of six for rheumatoid factor (IgM). - Clinical disease activity improved in all patients despite cessation of immunosuppressive therapies, with a median 34% reduction in **DAS28-CRP** at latest follow-up; three of six patients achieved DAS28-CRP remission and ACR70 response. - Short-term tolerability was acceptable, meeting the primary safety endpoint and supporting progression to the phase 2 component. - ClinicalTrials.gov identifier reported: NCT06475495.
## Clinical Analysis & Structured Key Points
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Giezen](https://www.nature.com/articles/s41591-026-04603-3#auth-Julia_M_-Giezen-Aff5) [ORCID: orcid.org/0000-0003-1024-4028](https://orcid.org/0000-0003-1024-4028)[5](https://www.nature.com/articles/s41591-026-04603-3#Aff5) [na1](https://www.nature.com/articles/s41591-026-04603-3#na1), * [Murat Torgutalp](https://www.nature.com/articles/s41591-026-04603-3#auth-Murat-Torgutalp-Aff1-Aff2)[1](https://www.nature.com/articles/s41591-026-04603-3#Aff1),[2](https://www.nature.com/articles/s41591-026-04603-3#Aff2), * [Arne Sattler](https://www.nature.com/articles/s41591-026-04603-3#auth-Arne-Sattler-Aff1-Aff4)[1](https://www.nature.com/articles/s41591-026-04603-3#Aff1),[4](https://www.nature.com/articles/s41591-026-04603-3#Aff4), * [Ioanna Minopoulou](https://www.nature.com/articles/s41591-026-04603-3#auth-Ioanna-Minopoulou-Aff1)[1](https://www.nature.com/articles/s41591-026-04603-3#Aff1), * [Robert Biesen](https://www.nature.com/articles/s41591-026-04603-3#auth-Robert-Biesen-Aff1) [ORCID: 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orcid.org/0000-0002-3470-6947](https://orcid.org/0000-0002-3470-6947)[3](https://www.nature.com/articles/s41591-026-04603-3#Aff3),[19](https://www.nature.com/articles/s41591-026-04603-3#Aff19),[20](https://www.nature.com/articles/s41591-026-04603-3#Aff20), * [Georg Schett](https://www.nature.com/articles/s41591-026-04603-3#auth-Georg-Schett-Aff21-Aff22) [ORCID: orcid.org/0000-0001-8740-9615](https://orcid.org/0000-0001-8740-9615)[21](https://www.nature.com/articles/s41591-026-04603-3#Aff21),[22](https://www.nature.com/articles/s41591-026-04603-3#Aff22), * [Hans Ulrich Scherer](https://www.nature.com/articles/s41591-026-04603-3#auth-Hans_Ulrich-Scherer-Aff5) [ORCID: orcid.org/0000-0002-5700-5617](https://orcid.org/0000-0002-5700-5617)[5](https://www.nature.com/articles/s41591-026-04603-3#Aff5), * [Rene E. M. Toes](https://www.nature.com/articles/s41591-026-04603-3#auth-Rene_E__M_-Toes-Aff5) [ORCID: orcid.org/0000-0002-9618-6414](https://orcid.org/0000-0002-9618-6414)[5](https://www.nature.com/articles/s41591-026-04603-3#Aff5), * [Arnd Kleyer](https://www.nature.com/articles/s41591-026-04603-3#auth-Arnd-Kleyer-Aff1)[1](https://www.nature.com/articles/s41591-026-04603-3#Aff1), * [Ulrich Keller](https://www.nature.com/articles/s41591-026-04603-3#auth-Ulrich-Keller-Aff3-Aff18-Aff19-Aff20) [ORCID: orcid.org/0000-0002-8485-1958](https://orcid.org/0000-0002-8485-1958)[3](https://www.nature.com/articles/s41591-026-04603-3#Aff3),[18](https://www.nature.com/articles/s41591-026-04603-3#Aff18),[19](https://www.nature.com/articles/s41591-026-04603-3#Aff19),[20](https://www.nature.com/articles/s41591-026-04603-3#Aff20), * [Lars Bullinger](https://www.nature.com/articles/s41591-026-04603-3#auth-Lars-Bullinger-Aff3-Aff16-Aff19) [ORCID: orcid.org/0000-0002-5890-5510](https://orcid.org/0000-0002-5890-5510)[3](https://www.nature.com/articles/s41591-026-04603-3#Aff3),[16](https://www.nature.com/articles/s41591-026-04603-3#Aff16),[19](https://www.nature.com/articles/s41591-026-04603-3#Aff19), * [David Simon](https://www.nature.com/articles/s41591-026-04603-3#auth-David-Simon-Aff1-Aff2-Aff4-Aff21-Aff22) [ORCID: orcid.org/0000-0001-8310-7820](https://orcid.org/0000-0001-8310-7820)[1](https://www.nature.com/articles/s41591-026-04603-3#Aff1),[2](https://www.nature.com/articles/s41591-026-04603-3#Aff2),[4](https://www.nature.com/articles/s41591-026-04603-3#Aff4),[21](https://www.nature.com/articles/s41591-026-04603-3#Aff21),[22](https://www.nature.com/articles/s41591-026-04603-3#Aff22) [na2](https://www.nature.com/articles/s41591-026-04603-3#na2) & * … * [Gerhard Krönke](https://www.nature.com/articles/s41591-026-04603-3#auth-Gerhard-Kr_nke-Aff1-Aff2-Aff4-Aff18-Aff21-Aff22) [ORCID: orcid.org/0000-0002-7566-4325](https://orcid.org/0000-0002-7566-4325)[1](https://www.nature.com/articles/s41591-026-04603-3#Aff1),[2](https://www.nature.com/articles/s41591-026-04603-3#Aff2),[4](https://www.nature.com/articles/s41591-026-04603-3#Aff4),[18](https://www.nature.com/articles/s41591-026-04603-3#Aff18),[21](https://www.nature.com/articles/s41591-026-04603-3#Aff21),[22](https://www.nature.com/articles/s41591-026-04603-3#Aff22) [na2](https://www.nature.com/articles/s41591-026-04603-3#na2) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04603-3#citeas) [ Save article ](https://www.nature.com/articles/s41591-026-04603-3/save-research?_csrf=sORlnt6kATRayYPwbuk8WYvM-TNIvs6s) [ View saved research ](https://www.nature.com/saved-research) ## Abstract Chimeric antigen receptor (CAR) T cell-mediated B cell depletion has demonstrated efficacy in several autoimmune diseases. Here we report clinical and molecular data obtained during the nonrandomized phase 1 part of the phase 1/2 COMPARE trial, evaluating safety and efficacy of mivocabtagene autoleucel (miv-cel), an autologous fully human CD19 CAR T cell therapy, in rheumatoid arthritis (RA). Six patients (three men, three women) with severe, treatment-refractory, anti-citrullinated protein antibody (ACPA)-positive RA received a single infusion of miv-cel after stopping all disease-modifying antirheumatic drug treatments and after standard lymphodepletion therapy. Patients were followed for 36–52 weeks for safety and efficacy. Primary endpoints were the incidence and severity of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) and adverse events (AEs) within the first 4 weeks after treatment. Secondary and explorative endpoints assessed clinical efficacy and cellular and humoral immune responses. CRS occurred in all patients and was limited to grade 1 and 2 events. No ICANSs or serious AEs occurred; one dose-limiting toxicity was recorded (grade 3 transaminase elevation, resolved without sequelae). The primary endpoint was met with acceptable safety findings, allowing advancement to phase 2. CAR T cell therapy resulted in depletion of CD19+ B cells across blood and tissue, coinciding with a continuous decline of autoantibodies with seroconversion in four of the six patients for ACPAs against mutated citrullinated vimentin and five of six for rheumatoid factor immunoglobulin M. Despite cessation of immunosuppressive treatments, disease activity improved in all patients (median 34% DAS28-CRP reduction at the latest follow-up with DAS28-CRP remission and American College of Rheumatology 70% response in 3 of 6 patients). CD19 CAR T cells showed acceptable short-term tolerability in patients with treatment-refractory RA, justifying further evaluation. ClinicalTrials.gov identifier: [NCT06475495](https://clinicaltrials.gov/study/NCT06475495?locStr=Berlin,%20Germany&country=DE&state=Berlin&city=Berlin&cond=Rheumatoid%20Arthritis&intr=CD19%20CAR-T%20cells&viewType=Card&rank=1). This is a preview of subscription content, [access via your institution](https://wayf.springernature.com?redirect_uri=https%3A%2F%2Fwww.nature.com%2Farticles%2Fs41591-026-04603-3) ## Access options [ Acc
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