RECRUITING

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

Conditions

Systemic Lupus Erythematosus Lupus Lupus Erythematosus Lupus Nephritis CB-010 Extrarenal lupus Autoimmune disease Anti-CD19 CAR-T therapy Cell therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2025-03-18

Study Completion:2029-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06752876

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Caribou Biosciences

CONTACT

Please email

clinicaltrials@cariboubio.com

Study Locations (Sites)

Oncology Hematology Care

Cincinnati, Ohio, 45242

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-03-18

Study Completion Date2029-04

Study Record Updates

Study Start Date2025-03-18

Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

CB-010
Lupus nephritis
Lupus
Extrarenal lupus
Autoimmune disease
Anti-CD19 CAR-T therapy
Cell therapy

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus
Lupus
Lupus Erythematosus
Lupus Nephritis