NCT06752876WithdrawnPhase 1
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 18 Dec 2024
- Start date
- Dec 2027
- Primary completion date
- Apr 2029
- Lead sponsor
- Caribou Biosciences, Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT06752876
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Received a live vaccine ≤ 6 weeks prior to start of LD
Other illness
- 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
Other
- Patients for whom magnetic resonance imaging (MRI) studies are contraindicated or who cannot tolerate them
Who the study is looking for
- Clinical diagnosis of SLE according to 2019 EULAR/ACR classification criteria for at least 6 months
- Cohort 1 LN:
- Class III or IV lupus nephritis
- Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 mg/mg
- 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):
- SLEDAI-2K ≥ 8
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.