Systemic Lupus ErythematosusPhase 1GALLOPNCT06752876
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
A Phase 1 study testing CB-010 in people with Systemic Lupus Erythematosus and Lupus, run by Caribou Biosciences, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus
- What is being tested?
- CB-010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2027to Apr 2029
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of SLE according to 2019 EULAR/ACR classification criteria for at least 6 months
- Cohort 1 LN:
- Class III or IV lupus nephritis
- Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 mg/mg
- 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):
Show all 10Show fewer
- SLEDAI-2K ≥ 8
- 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
Who cannot join
- 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
About this study
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)
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).
Read the 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.
- Being tested
- CB-010
- Keywords
- CB-010, Lupus nephritis, Lupus, Extrarenal lupus, Autoimmune disease, Anti-CD19 CAR-T therapy, Cell therapy
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-010Drug
CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Lupus Nephritis (LN) | Experimental | Not described Receives: Drug: CB-010 |
| Cohort 2 Extrarenal Lupus (ERL) | Experimental | Not described Receives: Drug: CB-010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion
Measured: Through 28 days
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Measured: Through end of study (approximately 2 years)
Secondary outcomes (1)
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
Measured: Through end of study (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study startDec 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Why it stopped: Sponsor Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caribou Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752876
- Sponsor's protocol ID
- CB10LUPA
- Acronym
- GALLOP
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06752876
- Acronym / sponsor ID
- GALLOP / CB10LUPA
- Keywords
- CB-010, Lupus nephritis, Lupus, Extrarenal lupus, Autoimmune disease, Anti-CD19 CAR-T therapy, Cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Caribou Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Lupus Nephritis (LN) | Experimental | Drug: CB-010 |
| Cohort 2 Extrarenal Lupus (ERL) | Experimental | Drug: CB-010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical diagnosis of SLE according to 2019 EULAR/ACR classification criteria for at least 6 months
- Cohort 1 LN:
- Cohort 2 ERL (Patients with class I and II LN may be included in the ERL cohort if their SLEDAI-2K is ≥ 8):
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CB-010CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion | Drug | Cohort 1 Lupus Nephritis (LN), Cohort 2 Extrarenal Lupus (ERL) |
Primary outcome
Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion
Time frame: 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)
1 secondary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CB-010 in people with Systemic Lupus Erythematosus and Lupus, run by Caribou Biosciences, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion (time frame: Through 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.