NCT06285279

The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases

Recruiting now Phase 1 Last updated 11 June 2025

What this trial tests

Phase 1 trial testing FKC288 in Lupus Nephritis in 24 participants. Currently enrolling.

Timeline

4 March 2024

Primary endpoint
31 December 2026

31 December 2028

Quick facts

Lead sponsor	Nanjing University School of Medicine
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	4 March 2024
Primary completion	31 December 2026
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• FKC288 — full drug profile →

Conditions studied

• Lupus Nephritis — all drugs for Lupus Nephritis →
• ANCA-associated Vasculitis — all drugs for ANCA-associated Vasculitis →
• Membranous Nephropathy - PLA2R Induced — all drugs for Membranous Nephropathy - PLA2R Induced →
• IgG4-Related Diseases — all drugs for IgG4-Related Diseases →

Sponsor

Nanjing University School of Medicine

Who can join

Adults 18 to 65, any sex, with Lupus Nephritis or ANCA-associated Vasculitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\^6 cells/kg, 1.0×10\^6 cells/kg, 3.0×10\^6 cells/kg, and an alternative dose of 0.1×10\^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).

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 cell therapies for systemic lupus erythematosus.
   Dao LTM, Vu TT, Nguyen QT, Hoang VT, et al · · 2024 · cited 16× · PMID 38920310 · DOI 10.1093/stcltm/szae044
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. 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
6. 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
7. Acute kidney injury following CAR-T cell therapy: a nephrologist's perspective.
   Kanbay M, Mizrak B, Alper EN, Copur S, et al · · 2025 · cited 7× · PMID 39781479 · DOI 10.1093/ckj/sfae359
8. 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