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Engineered immune cells take aim at stubborn autoimmune disorder

NCT ID NCT07599280

Disease control Sponsor: Jian Zhu 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new therapy called universal STAR-T cells in about 6 adults with autoimmune thrombocytopenia (low platelets) that hasn't responded to standard treatments. The cells are designed to target and calm the overactive immune system. The main goals are to check safety and see if the treatment can improve platelet counts.

What this could mean

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

Active substance
Universal STAR-T cells (a type of engineered immune cell)
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat autoimmune low platelet counts.
What could go wrong
This is a very early Phase 1 trial with only 6 participants, so results may not apply broadly. Risks include severe immune reactions or lack of effectiveness.

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 6 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 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 ranges from 18 to 65 years old (including threshold), regardless of gender. 2. Confirmed diagnosis of a connective tissue disease (CTD) according to the latest international classification criteria, including but not limited to Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Antiphospholipid Syndrome (APS), and Undifferentiated Connective Tissue Disease (UCTD). 3. Confirmed diagnosis of CTD-associated immune thrombocytopenia meeting one of the following: Platelet count \< 30 × 10⁹/L; Platelet count \< 50 × 10⁹/L accompanied by bleeding tendency. 4. Bone marrow morphology consistent with the characteristics of immune thrombocytopenia (ITP). 5. Prior Treatment History: Failure to achieve partial remission (PR) after receiving at least one of the following regimens continuously for ≥ 3 months, or inability to maintain efficacy during glucocorticoid tapering: At least one course of glucocorticoid pulse therapy; Or high-dose glucocorticoids combined with one or more immunosuppressants (including biologics). 6\. Essential Organ Function Criteria: 1. Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use). Hemoglobin ≥60 g/L. 2. Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted). 3. Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines). 4. Coagulation: INR/PT ≤1.5×ULN. 5. Cardiovascular: Hemodynamic stability. 7. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating. 8\. Voluntary participation with signed informed consent and compliance. Exclusion Criteria: * Subjects who meet any of the following exclusion criteria will not be admitted to the study: 1. Individuals with a severe history of drug allergies or those with an allergic constitution; 2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections; 3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease); 4. Subjects whose cardiac function cannot tolerate the study interventions; 5. Subjects with congenital immunoglobulin deficiencies; 6. Subjects with a history of malignant tumors within the past five years; 7. Subjects with end-stage renal failure; 8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing; 9. Subjects with psychiatric disorders or severe cognitive dysfunction; 10. Subjects who have participated in other clinical trials within the past three months prior to enrollment; 11. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment; 12. Pregnant women or women planning to become pregnant; 13. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.

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Conditions

The condition(s) this trial relates to.

Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • No. 28, Fuxing Road, Haidian District, Beijing, China.

    Haidian, Beijing Municipality, China

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