Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Caribou Biosciences, Inc.
Participants enrolled can expect to be on the study for a total duration of approximately 2 years, during which there will be a screening period followed by a single administration of CB-010 and then 24 months of safety follow-up and monitoring.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of SLE according to 2019 EULAR/ACR classification criteria for at least 6 months
Cohort 1 LN:
1. Class III or IV lupus nephritis
2. Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 mg/mg
3. Refractory to glucocorticoids and at least 2 immunosuppressive therapies
Cohort 2 ERL (Patients with class I and II LN may be included in the ERL cohort if their SLEDAI-2K is ≥ 8):
1. SLEDAI-2K ≥ 8
2. Refractory to glucocorticoids, and at least 2 immunosuppressive therapies
Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
Females must be either of nonchildbearing potential, defined as postmenopausal or surgically sterile or agree to use a highly effective double barrier method of contraception or vasectomized partner
You may not be if
Has active severe central nervous system (CNS) lupus in the previous 3 months from planned LD start date
Has received any other investigational treatment for any indication within the 4 weeks or 5 half-lives
Prior treatment with cellular therapy (genetically modified cells), gene therapy directed at any target, allogenic or autologous stem cell transplant or organ transplant
History of infection with human immunodeficiency virus or evidence of hepatitis B or C virus infection
History of hypersensitivity to Cyclophosphamide, Fludarabine, or any of the components of CB-010
Received a live vaccine ≤ 6 weeks prior to start of LD
Patients for whom magnetic resonance imaging (MRI) studies are contraindicated or who cannot tolerate them
