A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases.
36-72 patients are planned to be enrolled in the dose-escalation trial.
Common Inclusion Criteria
Voluntarily sign an informed consent form, understand the study, and be willing and capable of completing all trial procedures.
Aged 18 to 70 years, regardless of gender.
At screening, the number of peripheral blood CD19-positive B cells determined by flow cytometry > 5 cells/μL.
Common Exclusion Criteria
History of malignant tumors (excluding cured and completely resected basal cell carcinoma, squamous cell skin carcinoma or cervical carcinoma in situ with a disease-free interval of at least 5 years post resection), or concurrent malignant tumors.
Complicated severe pulmonary diseases, including pulmonary hypertension graded ≥ Grade 3 per WHO functional classification, requirement for oxygen therapy via oxygen reservoir mask, non-invasive or invasive mechanical ventilation support at screening.
Known allergy, hypersensitivity, intolerance or contraindication to CD19/BCMA CAR-NK cells or any investigational medicinal ingredients (including fludarabine, cyclophosphamide and tocilizumab), or history of severe anaphylactic reactions.
Single group
anti-CD19/BCMA-UCAR-T cells
Biological/VaccinePatients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Single dose of anti-CD19/BCMA CAR T cells (KN3601) will infused using dose-escalation strategy.
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of anti-CD19/BCMA-UCAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Rui Therapeutics Co., Ltd
Collaborator
