Actively Recruiting
A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases
Led by Beijing GoBroad Hospital · Updated on 2025-09-11
44
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
O
Overland Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed/refractory autoimmune diseases.
CONDITIONS
Official Title
A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years old
- ECOG performance status 0-2
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test at screening and agree to use highly effective contraception from lymphodepletion through 2 years after dosing
- For Systemic Sclerosis (SSc): meet 2013 ACR/EULAR classification criteria, mRSS score greater than 10, at least one vital organ involved besides skin, relapsed or refractory to at least one immunosuppressant or biologic
- For Primary Sjogren's Syndrome (pSS): meet 2016 EULAR/ACR classification criteria, anti-Ro/anti-SSA antibody positive, ESSDAI score 5 or higher, relapsed or refractory to at least one immunosuppressant or biologic
You will not qualify if you...
- Active uncontrolled infection
- Chronic hepatitis B virus infection without or unwilling to receive prophylactic antiviral therapy or with detectable viral load
- Hepatitis C virus infection without completed curative treatment or with detectable viral load
- HIV antibody positive
- Syphilis antibody positive
- Active untreated or inadequately treated latent tuberculosis
- Serious infection requiring hospitalization or IV antimicrobial therapy within 3 months prior to screening
- Oral antimicrobial therapy within 1 month prior to screening
- Congenital long QT syndrome or QTcF interval 480 ms or higher at screening (unless due to pacemaker or bundle branch block)
- Uncontrolled hypertension (blood pressure 160/100 mm Hg or higher repeatedly), unstable angina, congestive heart failure above NYHA class II, acute ischemia signs, recent coronary interventions or infarction within 6 months, uncontrolled cardiac arrhythmia, poorly controlled diabetes or endocrine diseases, severe chronic pulmonary disease, or other serious medical conditions impairing treatment tolerance
- History of organ transplant
- Pregnancy or lactation
- Use of any other experimental medication within 4 weeks or 5 half-lives prior to study drug
- Use of biologics within 10 weeks or stem cell transplant within 6 months prior to study drug
- Prior CAR-T therapy
- Received live or attenuated vaccine within 4 weeks of starting treatment
- Presence of other autoimmune or autoinflammatory diseases affecting assessments
- For SSc patients: risk for scleroderma renal crisis, SSc-associated gastric antral vascular ectasia, severe gastrointestinal involvement causing malabsorption or failure
- For pSS patients: primary biliary cholangitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, China, 102206
Actively Recruiting
Research Team
S
Shaocong Miao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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