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Experimental CAR-T therapy takes aim at Hard-to-Treat scleroderma

NCT ID NCT06400303

Disease control Sponsor: Kyverna 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new treatment called KYV-101 for people with systemic sclerosis, a disease where the immune system attacks the body, causing skin and organ damage. The therapy uses a patient's own modified immune cells to target and destroy certain B cells that may drive the disease. Only 3 participants are enrolled, and the main goals are to check safety and see if the treatment can improve symptoms.

What this could mean

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

Active substance
KYV-101 (a type of CAR-T cell therapy made from the patient's own immune cells, designed to target and destroy B cells)
What this could lead to
If successful, this could point toward a new treatment option for systemic sclerosis that targets the immune system's role in the disease.
What could go wrong
This is a very early, small trial with only 3 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome and infections.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

3 people

The number who actually took part.

Started

Aug 2024

Finished

Jun 2026

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.

Key Inclusion Criteria 1. Clinical diagnosis of SSc according to 2013 ACR/EULAR classification 2. Clinical disease as follows: Classified as diffuse cutaneous SSc; ≤ 6 years since first non-Raynaud's sign or symptom; active disease 3. Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals Key Exclusion Criteria 1. Clinically significant ILD 2. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target 3. History of allogeneic or autologous stem cell transplant 4. Evidence of active hepatitis B or hepatitis C infection 5. Positive serology for HIV 6. Primary immunodeficiency 7. History of splenectomy 8. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject 9. Impaired cardiac function or clinically significant cardiac disease 10. Previous or concurrent malignancy with the following exceptions: 1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening) 2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening 3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening

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Conditions

The condition(s) this trial relates to.

autoimmune disease diffuse cutaneous systemic sclerosis diffuse scleroderma systemic sclerosis

As listed by the trial registrant

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

Systemic sclerosis Systemic sclerosis - 2013 acr/eular classification criteria Systemic sclerosis - diffuse cutaneous

Contacts and locations

Locations

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Stanford University Medical Center

    Palo Alto, California, 94305, United States

More trials for these conditions

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