A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangdong Ruishun Biotech Co., Ltd

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

24 Participants
are divided into 1 treatment group

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