CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia
Trial Parameters
Brief Summary
This trial is exploratory research aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD13-02, a universal CD7 CAR T therapy, in subjects with relapsed/refractory severe aplastic anemia (SAA)
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide written informed consent. * Age ≥18 years and ≤75 years. * Diagnosed with severe aplastic anemia: Diagnostic criteria refer to the UK Hematology Guidelines (Br J Haematol, 2024, 204(3): 784-804): 1) Bone marrow cellularity \<25% (or 25-50% but \<30% residual hematopoietic cell area); 2) At least two of the following conditions must be met: ANC \<0.5×10\^9/L, PLT \<20×10\^9/L, absolute reticulocyte count \<60×10\^9/L; 3) Exclusion of other congenital or acquired hematopoietic failure disorders. * Had at least one course of standard-dose therapy with anti-thymocyte globulin (ATG) or anti-lymphocyte globulin (ALG) combined with TPO-RA that was ineffective or relapsed after remission within the past 6 months. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Willing and able to comply with the study procedures. Exclusion Criteria: * Blood cell reduction and hypoplastic bone marrow diseases due to