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Can a single infusion of reprogrammed immune cells quiet lupus kidney disease?

NCT ID NCT07729826

Cure Sponsor: AbelZeta 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether a single infusion of a patient's own genetically modified immune cells, called C-CAR168, can safely and effectively treat lupus nephritis that has not responded to standard therapies. The cells are designed to target and eliminate specific immune cells that drive the disease. About 50 participants aged 14 to 70 will receive the infusion and be followed for two years to see if their kidney function improves.

What this could mean

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

Active substance
a single infusion of a patient's own immune cells engineered to target CD20 and BCMA proteins (C-CAR168 CAR-T cell therapy)
What this could lead to
If successful, this could offer a one-time treatment that resets the immune system and puts lupus nephritis into long-term remission without ongoing medication.
What could go wrong
This is an early-phase trial with only 50 participants, so results may not apply to everyone. CAR-T therapy carries serious risks, including cytokine release syndrome and long-term immune suppression.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

14 to 70 years

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: * Able to provide informed consent or assent where applicable. * Male or female aged 14-70 years, weighing at least 40 kg. * Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria. * Biopsy-confirmed ISN/RPS Class III or IV lupus nephritis, with or without Class V, within 6 months before screening. * Proteinuria meeting protocol-defined thresholds. * Refractory to standard therapy. * Meets corticosteroid taper requirements. * Positive ANA and/or anti-dsDNA and/or anti-Smith antibody. * Meets all protocol eligibility requirements. Exclusion Criteria: * Active uncontrolled infection * Active hepatitis B, hepatitis C, or HIV infection * Active tuberculosis * Pregnancy or breastfeeding * Prior gene therapy or CAR T-cell therapy * Active malignancy * Severe cardiovascular disease * Significant pulmonary disease * CNS disease precluding participation * Any condition that would interfere with study participation or safety

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Conditions

The condition(s) this trial relates to.

autoimmune disease lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Autoimmune diseases Lupus nephritis (LN) Systemic lupus erythematosus (SLE)

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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