Engineered immune cells take aim at stubborn autoimmune disorder
NCT ID NCT07599280
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Immune thrombocytopenia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World data may reveal which ITP treatments work best
- A diet tweak may boost platelets in a bleeding disorder
- Can a new drug calm the immune System's attack on blood cells?
- Double attack on blood disorder: could two drugs beat one for stubborn ITP?
- Could a cholesterol drug and antioxidant help treat a rare bleeding disorder?
- New hope for lupus patients with dangerous low platelet counts