Trials
Search / Trial NCT05654779

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

Trial Information

Current as of January 14, 2025

Terminated

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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;

About Institute Of Hematology & Blood Diseases Hospital, China

The Institute of Hematology & Blood Diseases Hospital in China is a leading clinical research institution specializing in hematology and related disorders. Renowned for its commitment to advancing medical knowledge and improving patient care, the Institute conducts innovative clinical trials aimed at developing novel therapies and treatment protocols. With a multidisciplinary team of experts, state-of-the-art facilities, and a robust ethical framework, the Institute is dedicated to enhancing the understanding and management of blood diseases, contributing significantly to global hematological research and patient outcomes.

Locations

Tianjin, Tianjin, China

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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