The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
P-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide will be administered intravenously.
Fludarabine will be administered intravenously.
Rimiducid will be used as a rescue therapy in the event of the occurrence of severe or life-threatening adverse events. It will be administered intravenously.
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGNumber of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1
Time frame: Day 1 up to Day 29
Number of Participants With Adverse Events (AEs)
Time frame: Up to 5 years
Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)
Time frame: Up to 5 years
B-cell Levels in the Blood
Time frame: Up to 5 years
Percentage of Participants who Achieve Sustained Drug-free Definition of Remission in SLE (DORIS)
Drug-free DORIS is defined as a SLEDAI-2K = 0 and a PGA \<0.5 (on a 3-point PGA-visual analog scale \[VAS\]), without corticosteroids or other immunosuppressants.
Time frame: From Week 24 through Week 52
Number of Participants With Anti-CAR T Antibodies
Time frame: Up to 5 years
Reference Study ID Number: GA45767 https://forpatients.roche.com/
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