NCT07441525 UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
| NCT ID | NCT07441525 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Autoimmune Hemolytic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2029-01-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subjects voluntarily participate in this trial and sign the informed consent form. * Aged ≥ 18 years and ≤ 75 years, regardless of gender. * Organ function and laboratory tests: 1. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for Gilbert's Syndrome). 2. Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance Rate ≥ 40 ml/min. 3. Oxygen saturation (SpO2) ≥ 92% in room air at rest. 4. Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%. * Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening. * Female subjects of childbearing potential must agree to use highly effective contraceptive methods from at least 28 days before the start of lymphodepletion to 12 months after reinfusion on RD06-05. Male subjects of childbearing potential must agree to use effective barrier co