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

September 16, 2025 updated by: Caribou Biosciences, Inc.

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)

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 Lupus Nephritis (LN)
Drug: CB-010
CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion
Experimental: Cohort 2 Extrarenal Lupus (ERL)
Drug: CB-010
CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion
Time Frame: Through 28 days
Through 28 days
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Time Frame: Through end of study (approximately 2 years)
Through end of study (approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the PK profile of a single infusion of CB-010 (i.e., CB-010 expansion and persistence)
Time Frame: Through end of study (approximately 2 years)
Concentration of CB-010 in blood samples over time
Through end of study (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caribou Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2027

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB10LUPA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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