NCT06569472

Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis

Clinical Study of CD19 Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Refractory Juvenile Dermatomyositis (RJDM)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I clinical trial to evaluate the efficacy and safety of CD19-targeted CAR-T in the treatment of refractory juvenile dermatomyositis (RJDM).The experiment was divided into two phases: dose exploration (Part A) and dose extension (Part B).

Detailed description

juvenile dermatomyositis (JDM) is a non-suppurative chronic autoimmune disease and the most common type of juvenile idiopathic inflammatory myopathy.Despite the active treatment measures, some JDM patients are still intolerant or unresponsive to the treatment, resulting in a high disability and mortality rate.Because CD19 is widely expressed on the surface of B lymphocytes, CD19 CAR-T can also cause deep depletion of other CD19+ B cells while killing cancer cells, which is expected to achieve immune reconstruction in patients with autoimmune diseases, and completely change the status quo that such patients need to take hormones and immunosuppressants for a long time.

Conditions

• Juvenile Dermatomyositis

Interventions

Type	Name	Description
BIOLOGICAL	CD19-targetd CAR-T	Subjects underwent lymphocyte clearance chemotherapy and then received a single intravenous cell infusion

Timeline

• Start date: 2024-07-02
• Primary completion: 2027-07-31
• Completion: 2028-07-31
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: China