Actively Recruiting
Safety and Efficacy of PRG-1801 in Recurrent/Refractory Primary Immune Thrombocytopenia (ITP)
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-11-28
6
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
S
Shenzhen Pregene Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single center, open-label, 3+3 dose escalation, early phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of PRG-1801 for patients with relapsed/refractory immune thrombocytopenia (ITP).
CONDITIONS
Official Title
Safety and Efficacy of PRG-1801 in Recurrent/Refractory Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with primary immune thrombocytopenia for at least 6 months
- Platelet count below 30 × 10^9/L within 48 hours before study participation
- Positive for anti-platelet glycoprotein autoantibodies such as GPIIb/IIIa
- Previous first-line and/or second-line ITP treatment was ineffective, relapsed, or difficult to maintain
- Normal heart function with ejection fraction ≥50% and no significant ECG abnormalities
- Creatinine clearance rate ≥30 mL/min
- Liver enzymes ALT and AST ≤3 times the upper limit of normal
- Total bilirubin and alkaline phosphatase ≤2 times the upper limit of normal (Gilbert's syndrome ≤3 times)
- Absolute lymphocyte count ≥0.5 × 10^9/L; neutrophil count ≥1 × 10^9/L; hemoglobin ≥60 g/L; platelet count ≥10 × 10^9/L
- Blood oxygen saturation greater than 92%
- Eligible for apheresis or venous blood collection with no contraindications
- Men of reproductive potential and women of childbearing age must agree to effective contraception until 1 year after study drug use
- Women of childbearing age must have negative pregnancy tests at screening and before infusion and not be breastfeeding
- Participant or guardian must agree to participate and sign informed consent
You will not qualify if you...
- Thrombocytopenia caused by myelodysplastic syndromes, early aplastic anemia, atypical aplastic anemia, or thrombotic thrombocytopenic purpura
- Bone marrow examination indicating myelofibrosis grade 2 or higher or other primary diseases causing thrombocytopenia
- Allergy to any component of the cell product
- Heart diseases including congestive heart failure NYHA class III or IV, recent myocardial infarction or coronary procedures within 6 months, significant ventricular arrhythmias, unexplained syncope, or severe non-ischemic cardiomyopathy
- Malignant tumors within the past 3 years except for well-treated cases with no active disease for at least 3 years
- Symptomatic deep vein thrombosis or pulmonary embolism within 6 months or need for anticoagulant therapy
- Participation in other interventional clinical studies within 1 month before screening
- Vaccination with live attenuated vaccines within 4 weeks before screening
- Stroke or epileptic seizure within 6 months (excluding old lacunar cerebral infarction)
- Recent immunosuppressive treatment or use of prednisone >10mg/day within 3 days before CAR-T reinfusion
- Treatment with B-cell depleting agents such as rituximab within 24 weeks unless B cells have recovered
- Immunoglobulin reinfusion within 4 weeks before CAR-T reinfusion
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active infection
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei, Ph.D&M.D
CONTACT
J
Jinhui Shu, Ph.D
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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