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)
Trial Parameters
Brief 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 Criteria
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 patients with lupus nephritis: Biopsy-proven Class III or IV (± Class V) active LN per 2018 ISN/RPS criteria within 12 months of screening Modified NIH activity index ≥ 1/24 UPCR ≥ 1g/g Key Exclusion criteria: Participants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required Prior treatment with CAR T-cell therapy, B-cell-targeting T-cell-depend