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Experimental Donor-Cell therapy takes aim at tough autoimmune diseases

NCT ID NCT06294236

Disease control Sponsor: Sana Biotechnology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tests a therapy called SC291, made from donor immune cells, in 7 people with severe lupus or vasculitis that hasn't improved with standard treatments. The goal is to see if it is safe and tolerable, and to get a first look at whether it can control the disease. Participants receive the cells after a short chemotherapy course to prepare their bodies.

What this could mean

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

Active substance
SC291 (a type of 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 autoimmune diseases that haven't responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 7 participants, so safety and effectiveness are not yet proven. There may be serious side effects, 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.

Participants

About 7 people

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

Started

Apr 2024

Expected to finish

Mar 2028

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.

Inclusion Criteria: 1. Age ≥18 and ≤75 2. For LN cohort: * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) * Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria * Refractory disease to ≥ 2 prior treatment regimens 3. For ERL cohort: * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE * Severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies 4. For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria Exclusion Criteria: 1. Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell) 2. For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder 3. For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome 4. For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA -

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis autoimmune disease granulomatosis with polyangiitis lupus erythematosus lupus nephritis microscopic polyangiitis systemic lupus erythematosus vasculitis

As listed by the trial registrant

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

Anti-neutrophil cytoplasmic antibody-associated vasculitis Granulomatous polyangiitis Lupus erythematosus Microscopic polyangiitis SLE (systemic lupus) Systemic lupus erythematosus

Contacts and locations

Locations

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

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