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Gene-Edited cell therapy for lupus trial pulled before it started

NCT ID NCT06752876

Disease control Sponsor: Caribou Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study aimed to test a single infusion of CB-010, a CRISPR-edited CAR-T cell therapy made from donor cells, in people with severe lupus that did not respond to standard treatments. The trial was withdrawn before enrolling any participants, so no results are available. The approach was designed to target and destroy faulty immune cells that drive lupus, but its safety and effectiveness remain untested.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CB-010 (a CRISPR-edited CAR-T cell therapy made from donor cells)
What this could lead to
If it works, this could point toward a new treatment option for people with severe lupus that hasn't responded to other therapies.
What could go wrong
This trial was withdrawn before enrolling any participants, so no data is available. CAR-T therapies carry risks like cytokine release syndrome and infections, and long-term safety is unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Dec 2027

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune disease lupus erythematosus lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus Lupus erythematosus Lupus nephritis Systemic lupus erythematosus

More trials for these conditions

Other studies related to the condition(s) this trial covers.