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 February 05, 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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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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