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TERMINATEDPHASE1

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

NCT05654779•Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

14 - 60 years

Sex

ALL

Healthy Volunteers

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 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;

Locations (2)

Beijing Gobroad BoRen Hospital

Beijing, Beijing Municipality, China

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

December 12, 2022

Primary Completion Date

September 26, 2023

Completion Date

September 26, 2023

Last Updated

February 11, 2026

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

LCAR-AMDR Cells Product

BIOLOGICAL

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2