NCT06752876

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)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Caribou Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	CB-010	CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Timeline

• Start date: 2027-12-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-12-31
• Last updated: 2025-09-19

Regulatory

• FDA-regulated drug study