Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Genentech, Inc.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 inc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 31 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2033
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06984341
Start Date
January 31 2026
End Date
November 1 2033
Last Update
December 10 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.