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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CLL1-/CD33 Targeted LCAR-AMDR Cells Product in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This is a prospective, single-arm, open-label, single dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-AMDR cells in subjects with relapsed/refractory Acute Myeloid Leukemia who received adequate standard therapy.

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;