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 × 10⁶ CAR⁺T cells/kg and 10 × 10⁶ CAR⁺T cells/kg, with the initial dose being 6 × 10⁶ CAR⁺T cells/kg. To reduce efficacy risks, the dose may be escalated to 10 × 10⁶ CAR⁺T 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
All participants will recevie CAR+T cells infusion with dose groups of 6 × 10⁶ CAR+T cells/kg and 10 × 10⁶ CAR+T cells/kg.
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGThe incidence rates of Serious Adverse Events that occur during treatment
Time frame: From the day of cell infusion to months 24 after cell infusion
The incidence rates of Treatment-Emergent Adverse Events that occur during treatment
Time frame: From the day of cell infusion to months 24 after infusion
The incidence rates of Adverse Events of Special Interest that occur during treatment
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: The proportion of subjects who achieve a sustained platelet response
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Overall Response Rate (ORR)
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Complete Response Rate (CR)
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: PartialResponse Rate (PR)
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Duration of Sustained Platelet Response
Time frame: From the day of cell infusion to months 24 after cell infusion
ITP: Duration of Complete Response
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: The proportion of subjects who achieve a durable hemoglobin response
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Overall Response Rate (ORR)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Complete Response Rate (CR)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: PartialResponse Rate (PR)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Complete Hematologic Response with CompensatedHemolysis (CRi)
Time frame: From the day of cell infusion to months 24 after cell infusion
AIAH: Duration of Response (DOR)
Time frame: From the day of cell infusion to months 24 after cell infusion
Evans Syndrome: CR: Shall include both AIHA-CR and ITP-CR.
Time frame: From the day of cell infusion to months 24 after cell infusion
Evans Syndrome: PR: AIHA/ITP (either) achieves CR/PR, or both achieve PR
Time frame: From the day of cell infusion to months 24 after cell infusion
EVANS Syndrome: Duration of response
Time frame: From the day of cell infusion to months 24 after cell infusion
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