About this trial
This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.
Eligibility criteria
Qualifiers
Voluntarily sign an ICF and expect to complete the subsequent follow-up.
Age 18~65 years old (including cut-off value), gender is not limited.
Diagnosed with SLE according to the 2019 EULAR/ACR version of the revised criteria.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 points; Anti-nuclear antibody titer ANA≥1:80, or positive anti-dsDNA and/or anti-Sm antibodies.
Disqualifiers
Other malignancies within 5 years prior to screening, except adequately treated non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix;
Major surgery requiring hospitalization within 4 weeks prior to screening or during screening;
History of severe drug allergies or anaphylactic constitution;
Renal disease: Diagnosed with active severe lupus nephritis within 8 weeks prior to screening, requiring treatment with drugs prohibited by the study protocol for the treatment of active nephritis, hemodialysis or prednisone dose ≥ 100 mg/d, or equivalent glucocorticoids for ≥14 days; Creatinine clearance rate < 60mL/min and serum creatinine > 1.5 times ULN within 1 week before lymphodepleting chemotherapy;
Trial design
Treatments tested in this trial
- RJMty19 (CD19-CAR-DNT cells)
Treatment groups
Sponsors and collaborators
Guangdong Ruishun Biotech Co., Ltd
Lead sponsor
RenJi Hospital
Collaborator
Peking University People's Hospital
Collaborator
Changhai Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator