NCT06347718: CASTLE

CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

Recruiting now Phase 1, PHASE2 Last updated 30 September 2025

What this trial tests

Phase 1, PHASE2 trial testing anti-CD19 CAR T cell therapy in Systemic Lupus Erythematosus in 24 participants. Currently enrolling.

Timeline

17 July 2023

Primary endpoint
31 May 2026

31 May 2026

Quick facts

Lead sponsor	Miltenyi Biomedicine GmbH
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	17 July 2023
Primary completion	31 May 2026
Estimated completion	31 May 2026
Sites	1 location across Germany

Drugs / interventions tested

• anti-CD19 CAR T cell therapy — full drug profile →

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
• Systemic Sclerosis — all drugs for Systemic Sclerosis →
• Dermatomyositis — all drugs for Dermatomyositis →
• Polymyositis — all drugs for Polymyositis →

Sponsor

Miltenyi Biomedicine GmbH — full company profile →

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus or Systemic Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
   Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
2. Application of novel CAR technologies to improve treatment of autoimmune disease.
   Cheever A, Kang CC, O'Neill KL, Weber KS. · · 2024 · cited 18× · PMID 39445021 · DOI 10.3389/fimmu.2024.1465191
3. Current advancements in cellular immunotherapy for autoimmune disease.
   Berry CT, Frazee CS, Herman PJ, Chen S, et al · · 2025 · cited 15× · PMID 39821376 · DOI 10.1007/s00281-024-01034-5
4. CAR immunotherapy in autoimmune diseases: promises and challenges.
   Yu J, Yang Y, Gu Z, Shi M, et al · · 2024 · cited 13× · PMID 39411714 · DOI 10.3389/fimmu.2024.1461102
5. CD19 CAR-T cells for treatment-refractory autoimmune diseases: the phase 1/2 CASTLE basket trial.
   Müller F, Hagen M, Wirsching A, Kharboutli S, et al · · 2026 · cited 12× · PMID 41501497 · DOI 10.1038/s41591-025-04185-6
6. CAR T-cell therapy in autoimmune diseases: a promising frontier on the horizon.
   Wu D, Xu-Monette ZY, Zhou J, Yang K, et al · · 2025 · cited 9× · PMID 40873568 · DOI 10.3389/fimmu.2025.1613878
7. CAR-T-Cell Therapy for Systemic Lupus Erythematosus: A Comprehensive Overview.
   Abdalhadi HM, Chatham WW, Alduraibi FK. · · 2024 · cited 7× · PMID 39408836 · DOI 10.3390/ijms251910511
8. CAR-based cell therapy for autoimmune diseases.
   Li X, He C, Wang K, Xu GY, et al · · 2025 · cited 2× · PMID 41050649 · DOI 10.3389/fimmu.2025.1613622