The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
NCT Number: NCT07155369
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Xuzhou, China
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
UCAR-T cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide will be administered intravenously.
Fludarabine will be administered intravenously.
Time frame: 2 years
The incidence and severity of adverse events (AEs)
Time frame: 2 years
Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
Time frame: 2 years
AUC0-28d
Time frame: 2 years
Cmax
Time frame: 2 years
Tmax
Time frame: 2 years
Changes in B-cell levels in the peripheral blood from baseline.
The Affiliated Hospital of Xuzhou Medical University
Other
A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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