CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Dec 8, 2022

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Eligibility criteria

• Inclusion Criteria:
• • 1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF)（For minors, the guardian shall also provide written informed consent ）; Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
• • 2. Age 14-60 years;
• • 3. ECOG score: ≤2;
• 4. Relapsed/refractory AML must meet one of the following conditions:
• • 1. Twice or more relapse;
• • 2. Newly diagnosed AML patients who failed after 2 cycles of standard chemotherapy;
• • 3. Relapse within 12 months after CR, or relapse after 12 months with CR but failed to respond to conventional chemotherapy;
• • 4. Persistent extramedullary leukemia.
• • 5. Meet the requirements of allogeneic HSCT
• • 6. Expected survival ≥ 3 months;
• Exclusion Criteria:
• • 1. Subject with APL/AML-M3:t(15;17)(q22;q12)
• 2. Received any of the following treatments:
• • Previous allo-HSCT(Subjects who received allo-HSCT for more than 6 months, have stopped immunosuppressive drugs and have no active GvHD are not included in the exclusion criteria)
• • Previous gene therapy
• • Previous anti CD33/CLL1 therapy
• • Previous any target CAR-T cells therapy
• • 3. Prior antitumor therapy with insufficient washout period;
• • 4. CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission;
• • 5. HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive;
• • 6. Pregnant or breast-feeding women;