Actively Recruiting
An Open-Label Phase I Study Evaluating Safety and Pharmacokinetics of OL-CD19-GDT CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Diseases
Led by Beijing GoBroad Hospital · Updated on 2025-09-11
44
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of a CAR-T cell therapy called OL-CD19-GDT in adults with relapsed or refractory autoimmune diseases such as Systemic Sclerosis (SSc) and Primary Sjogren's Syndrome (pSS). This open-label, single-arm clinical study is designed to understand how this investigational treatment behaves in the body and its potential benefits for these conditions. Participants will receive OL-CD19-GDT through an intravenous bolus with ascending dose levels to find the recommended dose for further studies. The study includes one treatment phase with follow-up for up to two years to monitor effects and safety. OL-CD19-GDT administration is preceded by lymphodepletion to prepare the body for treatment. During the study, participants will undergo evaluations for dose-limiting toxicity within 30 days after receiving OL-CD19-GDT and monitoring for treatment-emergent adverse events throughout the study period, up to two years. Researchers will also track overall response rates, pharmacokinetics measures such as maximum concentration and time to maximum concentration of OL-CD19-GDT, serum cytokine levels, immunogenicity, and replication-competent virus levels. Safety and health assessments will be regularly performed to observe participants' status over time.
CONDITIONS
Brief 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 to 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception from lymphodepletion through 2 years after treatment
- For Systemic Sclerosis (SSc): meet 2013 ACR/EULAR criteria, mRSS score over 10, at least one vital organ involved beyond skin, relapsed or refractory to at least one immunosuppressant or biologic
- For Primary Sjogren's Syndrome (pSS): meet 2016 EULAR/ACR criteria, antibody positive for anti-Ro/anti-SSA, 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 infection without or unwilling to receive antiviral therapy or detectable viral load
- Hepatitis C infection without completed curative treatment or detectable viral load
- HIV antibody positive
- Syphilis antibody positive
- Active or untreated tuberculosis or latent tuberculosis infection
- Serious infections requiring hospitalization within 3 months or antimicrobial therapy within 1 month before screening
- Congenital long QT syndrome or corrected QT interval 480 ms or longer unless caused by pacemaker or bundle branch block
- Uncontrolled hypertension, unstable angina, congestive heart failure above NYHA class II, recent heart ischemia or infarction, uncontrolled arrhythmias, poorly controlled diabetes or other endocrine diseases, severe lung disease, or other serious medical conditions
- History of organ transplant
- Pregnant or breastfeeding women
- Use of experimental medication within 4 weeks or 5 half-lives before study drug
- Use of biologics within 10 weeks or stem cell transplant within 6 months before study drug
- Prior CAR-T cell therapy
- Live or attenuated vaccine within 4 weeks before treatment
- Other autoimmune or inflammatory diseases affecting study assessments such as rheumatoid arthritis, gout, or active fibromyalgia
- For SSc patients: risk of scleroderma renal crisis, gastric antral vascular ectasia, or severe gastrointestinal disease causing malabsorption or failure
- For pSS patients: presence of primary biliary cholangitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days after administration
Participants receive OL-CD19-GDT CAR-T cell therapy through intravenous bolus infusion with ascending dose levels to determine the recommended dose.
Multiple visits during treatment and up to 30 days post-treatment
Duration - Up to 2 years
Participants are monitored for safety, treatment response, and pharmacokinetics for up to 2 years after treatment.
Regular visits for safety and efficacy assessments over 2 years
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, China, 102206
Actively Recruiting
Research Team
S
Shaocong Miao
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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