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NCT06691152: SLE

Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus Erythematosus

Recruiting now Phase 1 Last updated 15 November 2024
What this trial tests

Phase 1 trial testing CD19 Universal CAR-T cells in Systemic Lupus Erythematosus in 18 participants. Currently enrolling.

Timeline
30 October 2024
Primary endpoint
30 September 2027
30 September 2027

Quick facts

Lead sponsorThe Children's Hospital of Zhejiang University School of Medicine
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date30 October 2024
Primary completion30 September 2027
Estimated completion30 September 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Who can join

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

Sponsor's own description

This is an investigator-initiated trial to evaluate the safety and efficacy of CD19 Universal CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Publications & conference data

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

  1. 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
  2. Innovations in immunotherapy for autoimmune diseases: recent breakthroughs and future directions.
    Alsayb MA. · · 2025 · cited 2× · PMID 41041324 · DOI 10.3389/fimmu.2025.1647066
  3. Research progress on chimeric antigen receptor-based immunotherapy against autoimmune diseases.
    Jiang M, Zhao J, Yuan J, Yu Z, et al · · 2025 · cited 2× · PMID 40747591 · DOI 10.1080/21645515.2025.2538350
  4. Roads and detours for CAR T cell therapy in autoimmune diseases.
    Avouac J, Barzel A, Caiati D, Davis RS, et al · · 2026 · cited 1× · PMID 41588112 · DOI 10.1038/s41573-025-01349-4
  5. Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
    Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7
  6. CAR T cells in pediatric systemic lupus erythematosus.
    Simopoulou T, Gkoutzourelas A, Katsiari CG. · · 2026 · cited 1× · PMID 40646368 · DOI 10.1007/s10067-025-07550-5
  7. Prospects for Development and Commercialisation of Allogeneic CAR-Based Therapies for Autoimmune Disease.
    Osborne M, Maher J. · · 2025 · PMID 41463563 · DOI 10.3390/biology14121790
  8. CAR-T therapy: pioneering a new era in the treatment of autoimmune diseases.
    Wu Y, Han L, Wang Y, Gu M, et al · · 2025 · PMID 40881712 · DOI 10.3389/fimmu.2025.1625166

Verify or expand the search:

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

Other The Children's Hospital of Zhejiang University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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