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Experimental CAR-T therapy takes on tough lupus cases

NCT ID NCT06984341

Disease control Sponsor: Genentech, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 06, 2026 · Updated 4 times

Summary

This early-stage trial tests a new treatment called P-CD19CD20-ALLO1, a type of CAR-T cell therapy, for people with severe lupus that hasn't improved with standard treatments. The study will enroll 162 participants and aims to check if the therapy is safe and tolerable. It also looks at how the cells behave in the body and whether they can reduce lupus activity, possibly leading to drug-free remission.

What this could mean

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

Active substance
P-CD19CD20-ALLO1 cells (a type of CAR-T cell therapy)
What this could lead to
If successful, this could lead to a new treatment option for people with severe lupus that hasn't responded to other therapies, potentially inducing long-term remission without ongoing medication.
What could go wrong
This is an early Phase 1 trial, so safety and effectiveness are not yet proven. There are risks of severe side effects from the cell therapy and chemotherapy, and the treatment may not work for everyone.

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

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2033

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 to 75 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.

Key Inclusion criteria: 18-75 years old SLE diagnosis per 2019 EULAR/ACR classification criteria ≥ 24 weeks Autoantibody positive and low complement at screening Treatment refractory: Failed ≥ 2 treatments for at least 3 months Highly active disease: SLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings) BILAG-2004 cat A in ≥ 1 organ system and/or cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and/or mucocutaneous organ systems for category B) PGA score ≥ 1.0 on a 0 to 3 VAS For patients with lupus nephritis: Biopsy-proven Class III or IV (± Class V) active LN per 2018 ISN/RPS criteria within 12 months of screening Modified NIH activity index ≥ 1/24 UPCR ≥ 1g/g Key Exclusion criteria: Participants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required Prior treatment with CAR T-cell therapy, B-cell-targeting T-cell-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant Significant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study Active severe or unstable neuropsychiatric disease Protocol-specified active or chronic infections, recent major episode of infection High-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH/MAS, substance abuse within the previous year) Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus

Contacts and locations

Locations

  • University of Alabama at Birmingham: The Kirklin Clinic

    Birmingham, Alabama, 35233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

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