CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)

Launched by CARIBOU BIOSCIENCES, INC. · Dec 20, 2024

Keywords

ClinConnect Summary

The GALLOP clinical trial is testing a new treatment for patients with a severe form of Systemic Lupus Erythematosus (SLE), a condition that can affect many parts of the body and cause serious health issues. This study is focused on using a special type of genetically modified immune cell therapy, called CB-010, to see if it is safe and effective for those whose lupus has not responded to traditional treatments. Participants will receive a single infusion of this therapy and will be closely monitored to understand how well it works.

To be eligible for the trial, patients must have been diagnosed with SLE for at least six months and have specific types of kidney involvement (lupus nephritis) or other severe symptoms. They should also have tried and not succeeded with standard treatments like steroids and other immune suppressants. Participants will need to meet certain health criteria and females must use effective birth control if they can become pregnant. Throughout the trial, patients can expect regular check-ups and tests to ensure their safety and track the therapy's effects. This study is currently recruiting participants of all genders aged 65 and older.

Gender

ALL

Eligibility criteria

• 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