Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CD19-targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases Mediated by Autoantibodies.

Nanjing Bioheng Biotech Co., Ltd.1 site in 1 country18 target enrollmentAugust 31, 2024

ConditionsSclerosis ANCA Associated Vasculitis IIM SS MS NMO Spectrum Disorder MG

InterventionsRD06-04 cell infusion

DrugsRD06-04 cell infusion

Overview

Phase: Early Phase 1
Intervention: RD06-04 cell infusion
Conditions: Sclerosis
Sponsor: Nanjing Bioheng Biotech Co., Ltd.
Enrollment: 18
Locations: 1
Primary Endpoint: Incidence of treatment-emergent adverse events, serious adverse events and incidence of adverse events of special inte rest
Status: Withdrawn
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by autoantibodies. The study population includes patients with Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myasthenia Gravis (MG).

Registry

clinicaltrials.gov

Start Date

August 31, 2024

End Date

August 31, 2027

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nanjing Bioheng Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects voluntarily participated in the study and signed the informed consent form.
•Age ≥18 years old and ≤70 years old, both sexes.
•Organ function and laboratory tests:
•Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).
•Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
•Blood routine: neutrophil count ≥1×109/L, hemoglobin ≥60g/L, platelet count ≥20×109/L, lymphocyte count \>0.3×109/L.
•Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.
•Oxygen saturation (SpO2) ≥92% at rest in room air.
•Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.
•Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.

Exclusion Criteria

•SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.
•IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
•MG Patients: Presence of uncontrolled myasthenia gravis crisis within 2 weeks prior to screening.
•Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.
•There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.
•Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.
•Pregnant or breastfeeding women.
•Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.