CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in... | NCT06752876

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

NCT06752876

Sponsor

Caribou Biosciences, Inc.

Status

Withdrawn

Last Update Posted

Sep 19, 2025Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Systemic Lupus Erythematosus
Lupus
Lupus Erythematosus
Lupus Nephritis

Interventions

CB-010

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs

Expanded Access Info

Start Date

Dec 2027Estimated

Primary Completion Date

Apr 2029Estimated

Completion Date

Apr 2029Estimated

First Submitted Date

Dec 18, 2024

First Submission Date that Met QC Criteria

Dec 20, 2024

First Posted Date

Dec 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 19, 2025Actual

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Cohort 1 Lupus Nephritis (LN)	Experimental		Drug: CB-010
Cohort 2 Extrarenal Lupus (ERL)	Experimental		Drug: CB-010

Name	Type	Description	Arm Group Labels	Other Names
CB-010	Drug	CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion	Cohort 1 Lupus Nephritis (LN) Cohort 2 Extrarenal Lupus (ERL)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008180	Lupus Erythematosus, Systemic
D008181	Lupus Nephritis
D001327	Autoimmune Diseases

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D007154	Immune System Diseases
D005921	Glomerulonephritis