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Tests treatment safety and results for Immune Thrombocytopenia
Official title Safety and Efficacy of PRG-1801 in Recurrent/Refractory Primary Immune Thrombocytopenia (ITP)
ClinicalTrials.gov ID: NCT06519565
What this study is testing
What is PRG-1801?
PRG-1801 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for immune thrombocytopenia.
Also referred to as BCMA-targeting CAR-T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age ≥18 years, regardless of gender.
- 2\. Clinically diagnosed with primary immune thrombocytopenia for at least 6 months, with a platelet count \<30×10\^9/L within 48 hours before...
- 3\. Positive for anti-platelet glycoprotein autoantibodies (such as GPIIb/IIIa).
- 4\. Previously received first-line and/or second-line ITP treatment (first-line treatment includes: corticosteroids or immunoglobulins; second-line...
- 5\. Basic normal function of important organs:
You likely can't join if
- 1\. Thrombocytopenia caused by myelodysplastic syndromes, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.
- 2\. Bone marrow examination during the screening period suggests myelofibrosis MF≥2 (European consensus scoring standard Thieleja2005) or bone marrow...
- 3\. Allergic history to any component in the cell product.
- 4\. Suffering from any of the following heart diseases:
- Congestive heart failure of NYHA class III or IV.
- Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months before signing the ICF.
See the full eligibility criteria
- 1\. Age ≥18 years, regardless of gender.
- 2\. Clinically diagnosed with primary immune thrombocytopenia for at least 6 months, with a platelet count \<30×10\^9/L within 48 hours before participating in the study.
- 3\. Positive for anti-platelet glycoprotein autoantibodies (such as GPIIb/IIIa).
- 4\. Previously received first-line and/or second-line ITP treatment (first-line treatment includes: corticosteroids or immunoglobulins; second-line treatment includes thrombopoietin receptor agonists (such as...
- 5\. Basic normal function of important organs:
- Echocardiography indicates an ejection fraction ≥50%, and the electrocardiogram shows no significant abnormalities.
- Creatinine clearance rate (CrCl) (Cockcroft-Gault formula) ≥30 mL/min.
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3.0× the upper limit of normal (ULN).
- Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0×ULN (Gilbert's syndrome ≤ 3.0×ULN).
- Absolute lymphocyte count (ALC) ≥0.5×10\^9/L; absolute neutrophil count (ANC) ≥1×10\^9/L; hemoglobin (Hb) ≥60 g/L; platelet count ≥10×10\^9/L.
- Blood oxygen saturation \>92%.
- 6\. Meet the standards for apheresis or venous blood collection, and have no contraindications to cell collection.
- 7\. Men of reproductive potential and women of childbearing age must agree to use effective contraception from the signing of the informed consent form until 1 year after the use of the study drug. Blood pregnancy tests...
- 8\. The participant or their guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating their understanding of the purpose and procedures of this clinical trial and their...
- 1\. Thrombocytopenia caused by myelodysplastic syndromes, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.
- 2\. Bone marrow examination during the screening period suggests myelofibrosis MF≥2 (European consensus scoring standard Thieleja2005) or bone marrow examination indicates the presence of primary diseases other than ITP...
- 3\. Allergic history to any component in the cell product.
- 4\. Suffering from any of the following heart diseases:
- Congestive heart failure of NYHA class III or IV.
- Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months before signing the ICF.
- Clinically significant ventricular arrhythmias, or history of unexplained syncope (excluding vasovagal syncope or dehydration).
- Severe non-ischemic cardiomyopathy history.
- 5\. Malignant tumors within the past 3 years before screening, except for the following: malignant tumors that have been treated radically and have no known active disease for ≥3 years before enrollment; or well-treated...
- 6\. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months or currently requiring anticoagulant therapy.
- 7\. Participation in other treatment clinical studies within 1 month before screening.
- 8\. Vaccination with attenuated live vaccines within 4 weeks before screening.
- 9\. Stroke or epileptic seizure within 6 months before signing the ICF (excluding old lacunar cerebral infarction).
- 10\. The following treatments before CAR-T reinfusion: immunosuppressive treatment within 3 days; use of prednisone (or equivalent drugs) at a dose \>10mg/day within 3 days.
- 11\. The following treatments before CAR-T reinfusion: treatment with B-cell depleting agents such as rituximab within 24 weeks (unless B cells have recovered); immunoglobulin reinfusion treatment within 4 weeks.
- 12\. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer detection exceeds the normal range; positive for hepatitis C virus (HCV)...
- 13\. Other conditions deemed unsuitable for participation in the study by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.