NCT06373081

Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease

Recruiting now NA Last updated 18 April 2024

What this trial tests

NA trial testing Anti-CD19-CD3E-CAR-T cells in Systemic Lupus Erythematosus (SLE) in 6 participants. Currently enrolling.

Timeline

20 April 2024

Primary endpoint
15 April 2025

15 April 2026

Quick facts

Lead sponsor	Shanghai Changzheng Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	20 April 2024
Primary completion	15 April 2025
Estimated completion	15 April 2026
Sites	1 location across China

Drugs / interventions tested

• Anti-CD19-CD3E-CAR-T cells — full drug profile →

Conditions studied

• Systemic Lupus Erythematosus (SLE) — all drugs for Systemic Lupus Erythematosus (SLE) →
• Sjogren's Syndrome — all drugs for Sjogren's Syndrome →
• Systemic Sclerosis — all drugs for Systemic Sclerosis →
• Inflammatory Myopathy — all drugs for Inflammatory Myopathy →

Sponsor

Shanghai Changzheng Hospital

Who can join

Adults 18 to 65, any sex, with Systemic Lupus Erythematosus (SLE) or Sjogren's Syndrome. 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 anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases.

Publications & conference data

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

1. 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
2. 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
3. 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
4. New Mechanisms and Therapeutic Targets in Systemic Lupus Erythematosus.
   Tian J, Zhou H, Li W, Yao X, et al · · 2025 · cited 7× · PMID 40491969 · DOI 10.1002/mco2.70246
5. Revolutionizing Autoimmune Kidney Disease Treatment with Chimeric Antigen Receptor-T Cell Therapy.
   Gu R, Shen J, Zhang J, Mao J, et al · · 2025 · cited 7× · PMID 40405911 · DOI 10.34133/research.0712
6. 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
7. Challenges and strategies in clinical applications of CAR-T therapy for autoimmune diseases.
   Chen X, Liu K, Liu B, Li S, et al · · 2025 · cited 4× · PMID 41316450 · DOI 10.1186/s13045-025-01769-0
8. Antiphospholipid Syndrome: An Antibody-Mediated Disease With Emerging Therapeutic Opportunities.
   Newman TG, Knight JS. · · 2025 · cited 4× · PMID 40386969 · DOI 10.1002/art.43258