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)

Launched by GENENTECH, INC. · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called P-CD19CD20-ALLO1 for people with severe systemic lupus erythematosus (SLE), a condition that can cause serious health problems. The trial aims to see how safe this treatment is, how well it works, and how the body responds to it. It will start by testing different doses of the treatment to find the safest and most effective amount, and then it will expand to include more participants. This study is specifically for adults aged 18 to 75 who have been diagnosed with SLE and have not responded well to at least two other treatments.

To be eligible for the trial, participants must have a confirmed diagnosis of SLE for at least six months and show signs of active disease. This means they have specific markers in their blood and meet certain criteria related to their symptoms. Participants who join the study can expect regular check-ups and monitoring throughout the process. It’s important to note that individuals who are pregnant, have certain medical conditions, or have had specific types of prior treatments will not be eligible for this trial. Overall, this study hopes to provide new insights into treating a challenging condition for those who have not found relief with standard therapies.

Gender

ALL

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-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant
• • Significant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study
• • Active severe or unstable neuropsychiatric disease
• • Protocol-specified active or chronic infections, recent major episode of infection
• • High-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH/MAS, substance abuse within the previous year)
• • Other protocol-defined inclusion/exclusion criteria apply