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)
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.
162 participants
Jun 30, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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
Exclusion Criteria6
- 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)
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06984341