A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Patients With Severe, Treatment-refractory Systemic Lupus Erythematosus
Genentech, Inc.
Summary
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion criteria: 18-75 years old SLE diagnosis per 2019 EULAR/ACR classification criteria ≥ 24 weeks Autoantibody positive and low complement at screening Treatment refractory: Failed ≥ 2 treatments for at least 3 months Highly active disease: SLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings) BILAG-2004 cat A in ≥ 1 organ system and/or cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and/or mucocutaneous organ systems for category B) PGA score ≥ 1.0 on a 0 to 3 VAS For pat…
Interventions
- BiologicalP-CD19CD20-ALLO1 Cells
P-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.
- DrugCyclophosphamide
Cyclophosphamide will be administered intravenously.
- DrugFludarabine
Fludarabine will be administered intravenously.
- DrugRimiducid
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.
Locations (2)
- University of Alabama at Birmingham: The Kirklin ClinicBirmingham, Alabama
- University of IowaIowa City, Iowa