Clareo Health | 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 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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
