Overview

This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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