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

NCT ID: NCT06752876

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-12-31
• Study Completion Date: 2029-04-30

Brief Summary

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).

Detailed Description

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.

Conditions

Systemic Lupus Erythematosus; Lupus; Lupus Erythematosus; Lupus Nephritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 Lupus Nephritis (LN)

Group Type: EXPERIMENTAL

CB-010

Intervention Type: DRUG

CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Cohort 2 Extrarenal Lupus (ERL)

Group Type: EXPERIMENTAL

CB-010

Intervention Type: DRUG

CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Interventions

CB-010

CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Caribou Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CB10LUPA

Identifier Type: -

Identifier Source: org_study_id