OL-CD19-GDT CAR‑T for relapsed or refractory systemic sclerosis and primary Sjögren's syndrome

An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-CD19-GDT) in the Treatment of Relapsed/Refractory Autoimmune Diseases

This trial will try the CAR‑T therapy OL‑CD19‑GDT in adults whose systemic sclerosis or primary Sjögren's syndrome has relapsed or not responded to other treatments to see if it is safe and helps.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing GoBroad Hospital (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 1 site (Beijing)
• Trial ID: NCT07167537 on ClinicalTrials.gov

What this trial studies

This is an open‑label, single‑arm Phase 1 trial administering OL‑CD19‑GDT CAR‑T cells to adults with relapsed or refractory systemic sclerosis (SSc) or primary Sjögren's syndrome (pSS). Eligible participants must meet specific classification criteria (2013 ACR/EULAR for SSc or 2016 ACR/EULAR for pSS), have active disease (e.g., mRSS >10 for SSc or ESSDAI ≥5 for pSS), and adequate organ function. Patients undergo lymphodepletion followed by a single infusion of the investigational CAR‑T product with planned pharmacokinetic and safety monitoring and serial assessments of disease activity and organ function. The primary focus is safety and tolerability with secondary data collected on pharmacokinetics and preliminary clinical activity.

Who should consider this trial

Good fit: Adults aged 18–65 with relapsed or refractory SSc (meeting 2013 ACR/EULAR criteria, mRSS >10, and at least one organ involvement) or pSS (meeting 2016 ACR/EULAR criteria, anti‑Ro/SSA positive, ESSDAI ≥5) who have adequate organ function and ECOG 0–2 are eligible.

Not a fit: Patients with active uncontrolled infections, untreated or uncontrolled chronic HBV, or who do not meet the specific disease, antibody, organ‑function, or performance status criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, OL‑CD19‑GDT could reduce disease activity and organ damage in patients who have not responded to existing immunosuppressants or biologics.

How similar studies have performed: Early case reports and small series of anti‑CD19 CAR‑T in autoimmune diseases such as severe lupus have shown encouraging remissions, but controlled data remain limited.

Eligibility criteria

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

Where this trial is running

Beijing

• Beijing GoBroad Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Shaocong Miao

Conditions Systemic Sclerosis; Primary Sjogren' s Syndrome