Study of P-CD19CD20-ALLO1 for Severe Lupus
This study is testing a new treatment called P-CD19CD20-ALLO1 for people with severe systemic lupus erythematosus (SLE), an autoimmune disease. Researchers want to see how safe P-CD19CD20-ALLO1 is, how well your body tolerates it, and if it helps improve your lupus. You would also receive cyclophosphamide and fludarabine, and rimiducid might be used if you have severe side effects. To join, you must be 18-75 years old, have a confirmed SLE diagnosis for at least 24 weeks, have specific autoantibodies and low complement levels, and your lupus must be highly active and not have responded to at least two previous treatments. The main goals are to track any side effects and how many participants experience them over up to 5 years. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 162 participants. It includes a dose-escalation stage followed by an expansion stage.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to 5 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1Day 1 up to Day 29
- Number of Participants With Adverse Events (AEs)Up to 5 years