Clinical Study on the Safety, Efficacy, and Pharmacokinetics of CAR-T Cell Injection Targeting CD19 in the Treatment of Patients With Active Autoimmune Diseases

Nanjing Bioheng Biotech Co., Ltd.1 site in 1 country12 target enrollmentSeptember 13, 2024

ConditionsSystemic Lupus Erythematosus Systemic Sclerosis ANCA Associated Vasculitis Idiopathic Inflammatory Myopathies Sjogren's Syndrome Autoimmune Diseases

InterventionsRD06-04 CART Cell Injection

Overview

Phase: Early Phase 1
Intervention: RD06-04 CART Cell Injection
Conditions: Systemic Lupus Erythematosus
Sponsor: Nanjing Bioheng Biotech Co., Ltd.
Enrollment: 12
Locations: 1
Primary Endpoint: The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment
Status: Suspended
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS

Registry

clinicaltrials.gov

Start Date

September 13, 2024

End Date

August 1, 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.
•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.