The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.
* The main questions it aims to answer are: What CAR-T-related adverse events (AEs) occur within 3 months after the UCAR-T cell infusion? Which dose level is the optimal biological dose (OBD)? What are the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS? * Participants will may receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) if clinically needed. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. Receive UCAR-T cells infusion on Day 0. Then be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after UCAR-T cells infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
intravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
Yancheng Third People's Hospital
Yancheng, Jiangsu, China
RECRUITINGThe General Hospital of Western Theater Command
Chengdu, Sichuan, China
NOT_YET_RECRUITINGthe incidence rate of Dose limited toxicity (DLTs)
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of UCAR-T cells.
Time frame: Up to 28 days after infusion
the rate of adverse events
The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included.
Time frame: up to 2 months after UCAR-T injection
Proportion of patients achieving DORIS remission
Time frame: up to 2 years after UCAR-T injection
the changes of SELENA-SLEDAI score
Time frame: up to 2 years after UCAR-T injection
Proportion of patients achieving SRI-4 remission
Time frame: up to 2 years after UCAR-T injection
Percentage of participants achieving maintenance of drug-free DORIS remission
Time frame: up to 2 years after UCAR-T injection
Percentage of participants achieving maintenance of LLDAS
Time frame: up to 2 years after UCAR-T injection
the changes of BILANG 2004 score
The BILAG 2004 score is a validated clinical assessment tool for systemic lupus erythematosus (SLE), which evaluates disease activity across 9 organ systems (constitutional, cutaneous, mucous membrane, musculoskeletal, renal, neurological, cardiovascular, respiratory, and hematological) using a 5-point grading scale (A=active/severe, B=active/mild-moderate, C=stable/minor activity, D=inactive, E=not involved) to guide treatment decisions and monitor therapeutic responses in clinical practice and research.
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Time frame: up to 2 years after UCAR-T injection
the changes of Physician's Global Assessment (PGA)
Time frame: up to 2 years after UCAR-T injection