Engineered immune cells take on autoimmune diseases in early trial
NCT ID NCT07167537
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial is testing a new treatment called OL-CD19-GDT, which uses specially engineered immune cells (CAR-T cells) from a healthy donor to target and destroy faulty immune cells in people with severe autoimmune diseases like systemic sclerosis and Sjogren's syndrome. The study will enroll 44 adults whose disease has returned or not responded to standard treatments. The main goals are to check the treatment's safety and find the right dose, while also looking at how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OL-CD19-GDT (allogeneic CAR-T cells targeting CD19)
- What this could lead to
- If successful, this could offer a new treatment option for people with severe autoimmune diseases that haven't responded to standard therapies.
- What could go wrong
- This is a very early (Phase 1) trial with only 44 participants, so safety and effectiveness are not yet proven. CAR-T therapy can cause serious side effects like cytokine release syndrome.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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: * Adults aged 18-65 years old * ECOG 0-2 * Adequate organ function * Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP * SSc specific: a)Fulfilling the 2013 ACR/EULAR classification criteria of SSc; b) mRSS score \>10; c) at least one vital organ involvement besides the skin; d)relapsed or refractory to at least one immunosuppressant or biologic. * pSS specfic: a)Fulling the 2016 EULAR/ACR classification critieria for pSS; b) anti-Ro/anti-SSA antibody positive; c) ESSDAI score ≥5 ; d)relapsed or refractory to at least one immunosuppressant or biologic. Exclusion Criteria: * Active uncontrolled infection * Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load * Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load * HIV antibody positive * Syphilis antibody positive * Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI) * History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections) * Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block) * Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment * history of organ transplant * Pregnancy or lactating women * Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug * Use of biologics within 10 weeks, stem cell transplant within 6 months prior to the start of study drug * Prior CAR-T treatment * Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1 * Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome. * Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure * Limited to patients diagnosed with pSS: primary biliary cholangitis
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing GoBroad Hospital
RECRUITINGBeijing, 102206, China
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