Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

Recruiting Phase 1 Phase 2 Interventional Study
Systemic Lupus Erythematosus Lupus Nephritis Autoimmune Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Granulomatous Polyangiitis Microscopic Polyangiitis Systemic Sclerosis Idiopathic Inflammatory Myopathies Sjogren's Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
Essen Biotech · Other
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * 18-90 years old; * Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria. * SELENA-SLEDAI≥8. * Patients with CD19+ B-cell. * Hemoglobin≥85 g/L. * WBC≥2.5×10\^9/L. * NEUT≥1×10\^9/L. * BPC≥50×10\^9/L. * AST/ALT below 2 times the upper limit of normal; Creatinine cle…
Contacts

Rhoda M Smith, Phd

+12077706670

clinical-trials@essen-biotech.com

CONTACT