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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06752876
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Caribou Biosciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus, Lupus Nephritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Cohort 1 Lupus Nephritis (LN)

Experimental: Cohort 2 Extrarenal Lupus (ERL)

Interventions

Drug: - CB-010

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Oncology Hematology Care, Cincinnati, Ohio

Status

Recruiting

Address

Oncology Hematology Care

Cincinnati, Ohio, 45242

Site Contact

Central Study Contact

[email protected]

Please email

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