A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy o… (NCT06984341) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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)
United States162 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1
Timeframe: Day 1 up to Day 29
2
Number of Participants With Adverse Events (AEs)
Timeframe: Up to 5 years
Trial details
NCT IDNCT06984341
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2033-11-01
Contact for this trial
Reference Study ID Number: GA45767 https://forpatients.roche.com/