RN1201 Injection in the Treatment of Antibody-Mediated Diseases (NCT07072247) | Clinical Trial Compass
Not Yet RecruitingPhase 1
RN1201 Injection in the Treatment of Antibody-Mediated Diseases
9 participantsStarted 2025-07-10
Plain-language summary
This single-arm, open-label exploratory trial aims to evaluate the safety, feasibility, and preliminary efficacy of RN1201 Injection in patients with antibody-mediated diseases, including refractory immune-mediated platelet transfusion refractoriness (PTR) and relapsed or refractory immune thrombocytopenia (ITP). Patients will receive RN1201 cells infusion following lymphodepletion. The study will assess safety, response rates, B-cell depletion, and immune reconstitution. Exploratory analyses will examine in vivo persistence and activity of RN1201.
Who can participate
Age range16 Years – 65 Years
SexALL
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Inclusion criteria
✓. Aged 16-65 years
✓. Diagnosed with refractory immune-mediated PTR
✓. Resistant to at least 3 standard therapies
✓. Able to understand the study and consent
✓. Projected survival time exceeding three months
✓. Left Ventricular Ejection Fraction (LVEF) ≥0.5 (as measured by echocardiogram)
✓. Creatinine \<1.6 mg/dL
✓. Aspartate Aminotransferase (AST) \< three times the upper limit of normal
Exclusion criteria
✕. Uncontrolled active infection
✕. Active hepatitis B or C infection
✕. Patient has HIV or syphilis infection
✕. Patient is pregnant or breastfeeding
✕. Patient has a history of allogeneic hematopoietic stem cell transplantation (allo-HSCT)
✕. Conventional treatment for antibody-mediated disease is effective
✕. According to the New York Heart Association (NYHA) classification, patients with Class III/IV cardiovascular dysfunction
What they're measuring
1
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
Timeframe: within 4 weeks after infusion
Trial details
NCT IDNCT07072247
SponsorThe First Affiliated Hospital of Soochow University