At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Primary ITP diagnosed for ≥6 months
- ✓Platelet count <30×10⁹/L within 48 hours before study entry
- ✓Positive for anti-platelet glycoprotein autoantibodies
- ✕Secondary thrombocytopenia (MDS, early aplastic anemia, TTP, etc.)
- ✕Myelofibrosis MF≥2 on bone marrow exam or other primary diseases causing thrombocytopenia
- ✕Allergy to cell product components
- ✕NYHA class III or IV congestive heart failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study on the Safety and Efficacy of PRG-1801 for the Treatment of Recurrent/Refractory Primary Immune Thrombocytopenia (ITP)
In Brief
A Early Phase 1 clinical trial evaluating PRG-1801 for Immune Thrombocytopenia. Currently recruiting, targeting 6 participants across 2 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
PRG-1801 is a chimeric antigen receptor T-cell (CAR-T) therapy targeting BCMA. Participants will undergo leukapheresis to collect mononuclear cells for PRG-1801 manufacturing. Prior to infusion, patients receive lymphodepletion with cyclophosphamide (250-300 mg/m2/day) and fludarabine (25-30 mg/m2/day) for 3 days. PRG-1801 is then administered as a single intravenous infusion at one of three dose levels: 100×10\^6, or 200×10\^6 CAR-T cells. Premedication with antipyretics and antihistamines is given 30-60 minutes before infusion. The infusion rate is 2-5 ml/min. Patients are monitored for safety and efficacy for up to 24 months post-infusion. Some patients may be eligible for a second infusion if they respond initially but later relapse.