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

WITHDRAWNPHASE1

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)

NCT06752876•Caribou Biosciences, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

December 1, 2027

Primary Completion Date

April 1, 2029

Completion Date

April 1, 2029

Last Updated

September 19, 2025

Conditions

Systemic Lupus ErythematosusLupusLupus ErythematosusLupus Nephritis

Interventions

CB-010

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus