CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria: 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; Age 14-60 years; ECOG score: ≤2; Relapsed/refractory AML must meet one of the following conditions: Twice or more relapse; Newly diagnosed AML patients who failed after 2 cycles of standard chemotherapy; Relapse within 12 months after CR, or relapse after 12 months with CR but failed to respond to conventional chemotherapy; Persistent extramedullary leukemia. Meet the requirements of allogeneic HSCT Expected survival ≥ 3 months; Exclusion Criteria: Subject with APL/AML-M3:t(15;17)(q22;q12) 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 Prior antitumor therapy with insufficient washout period; CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission; HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; Pregnant or breast-feeding women;
Sites / Locations
- Beijing Gobroad BoRen Hospital
- Chinese Academy of Medical Science and Blood Disease HospitalRecruiting
Arms of the Study
Arm 1
Experimental
LCAR-AMDR Cells Product
Each subject will be treated with LCAR-AMDR Cells