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Engineered immune cells take on lupus in tiny trial

NCT ID NCT06038474

Disease control Sponsor: Cartesian Therapeutics 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial is testing a new treatment called Descartes-08 for people with systemic lupus erythematosus (SLE). Descartes-08 uses a patient's own immune cells, modified to target a protein called BCMA, to try to control the disease. Only 6 participants with active lupus despite other treatments are being enrolled to check safety and see if the therapy shows any signs of working.

What this could mean

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

Active substance
Descartes-08 (a type of CAR T-cell therapy that targets BCMA)
What this could lead to
If it works, this could point toward a new treatment option for people with lupus that doesn't require lifelong medication.
What could go wrong
This is a very small, early-phase trial with only 6 participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome.
Why investors are watching

Cartesian Therapeutics is running a Phase II trial of Descartes-08, a CAR T-cell therapy, in six patients with systemic lupus erythematosus. For a small company, this early readout matters because it tests whether the therapy is safe, tolerable, and feasible to manufacture, which are the first hurdles before any larger efficacy study.

If it works: A positive result could show that Descartes-08 is safe and practical to produce, giving Cartesian a foundation to advance the therapy into larger trials and broaden its pipeline beyond this small study.

If it fails: A failure or delay in safety, tolerability, or manufacturing could set the program back and hurt the company's prospects, since small companies often depend on a single lead asset. Trials at this stage frequently fail, so the outcome is uncertain.

AI-written from the trial record. Speculative, and not investment advice.

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

6 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Dec 2027

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: * Patient must be at least 18 years of age. * Patient must have systemic lupus erythematosus (SLE) at the time of screening. * Active symptoms despite recent or ongoing immunosuppressive therapy with glucocorticoids and at least 2 other immunosuppressive medications being tried for at least 12 weeks within 24 months of screening. * At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodies detectable at screening as assessed by a CLIA-certified laboratory. Exclusion Criteria: * Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptoms of SLE including headache, seizure, psychosis, and organic brain syndrome (a patient with an incidental headache, deemed unrelated to SLE, may re-screen by telephone upon resolution of the headache); * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient. * Patient is pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus (SLE)

Contacts and locations

Locations

  • Profound Research LLC

    Oceanside, California, 92056, United States

More trials for these conditions

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