This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated autoimmune hematological diseases. The enrolled population consists of patients with active autoimmune hematological diseases, including primary immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), and Evans syndrome. This study sets two dose groups: 6 Ă 10ⶠCARâșT cells/kg and 10 Ă 10ⶠCARâșT cells/kg, with the initial dose being 6 Ă 10ⶠCARâșT cells/kg. To reduce efficacy risks, the dose may be escalated to 10 Ă 10ⶠCARâșT cells/kg following evaluation and recommendation by the Safety Review Committee (SRC). The SRC's recommendation on dose escalation will be based on a comprehensive assessment of all available safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data.
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The incidence rates of Serious Adverse Events that occur during treatment
Timeframe: From the day of cell infusion to months 24 after cell infusion
The incidence rates of Treatment-Emergent Adverse Events that occur during treatment
Timeframe: From the day of cell infusion to months 24 after infusion
The incidence rates of Adverse Events of Special Interest that occur during treatment
Timeframe: From the day of cell infusion to months 24 after cell infusion