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Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases

NCT06685042 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-04-11

No results posted yet for this study

Summary

The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM/PM, and AAV. These life-threatening conditions often resist current therapies, and B cells play a key role in their pathogenesis. The study employs CD19-CAR\_Lenti, an autologous CAR T-cell product targeting CD19-positive B cells, aiming to reduce inflammation and autoimmunity. This open-label, single-dose, phase I basket trial will assess the safety, feasibility, and preliminary efficacy of CAR T-cell therapy, focusing on adverse events, infection rates, and overall response at 24 weeks. Eight participants will be included.

Conditions

  • Lupus Erythematosus, Systemic
  • System; Sclerosis
  • ANCA Associated Vasculitis
  • Dermatomyositis
  • Polymyositis

Interventions

BIOLOGICAL

CAR T cell

The investigational medicinal product (IMP) "CD19-CAR\_Lenti" consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells, derived from a leukapheresis product and processed by using the CliniMACS Prodigy® device (Miltenyi Biotec). CD19-CAR\_Lenti is a suspension of fresh CD4/CD8-enriched CD3+ T cells that have been genemodified with a self-inactivating (SIN) lentiviral vector expressing a CAR directed against human CD19. The SIN lentiviral vector is derived from clinically validated viral vectors described in the literature with a fully characterized sequence.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Maria Antonietta D'Agostino · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-29
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06685042 on ClinicalTrials.gov