To hear about similar clinical trials, please enter your email below
Trial Title:
Allogenic CD123-CAR-NK Cells in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia
NCT ID:
NCT05574608
Condition:
Acute Myeloid Leukemia Refractory
Acute Myeloid Leukemia Recurrent
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Evaluate the safety of JD023 injection.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD123-CAR-NK cells
Description:
CD123-CAR-NK is an allogenic CD123-Targeted chimeric antigen receptor NK-cell (CAR-NK)
therapy.
Arm group label:
Experimental: Experimental: CD123-CAR-NK.
Summary:
The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for
treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the
safety of CD123-CAR NK cells given to these patients.
Detailed description:
This is a study of allogenic CD123-CAR NK cells. The relapsed/refractory AML patients
will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion
of CD123-CAR-NK cells. No graft-versus-host disease (GVHD) prevention will be conducted
before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease
response and PK/PD will be detected post-infusion.
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. Age ≥ 18 years old, no gender or race;
2. Expected survival period ≥ 3 months;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
4. The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry
definitively positive for CD123 and met one of the following criteria:
A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia
cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for
other reasons such as bone marrow regeneration after consolidation chemotherapy) or
extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory
AML: naive patients who were ineffective after 2 courses of standard regimens;
patients relapsed within 12 months who underwent consolidation and intensive therapy
after CR; patients relapsed after 12 months but were ineffective after conventional
chemotherapy; Patients with two or more relapses; patients with persistent
extramedullary leukemia; C. Patients eligible for relapsed or refractory AML
remained minimally residual disease positive after salvage therapy
5. Adequate organ function:
A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation
function: international normalized ratio (INR) or activated partial thromboplastin
time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine
clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction
(LVEF) ≥ 50%;
6. Women of child-bearing potential and all male participants must use effective
methods of contraception for at least 12 months after infusion.;
7. Informed Consent/Assent: All subjects must have the ability to understand and the
willingness to sign a written informed consent.
Exclusion Criteria:
1. Central nervous system involved;
2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen
of fludarabine/cyclophosphamide;
3. Systemic use of hormones within 2 weeks prior to enrollment (except for patients
with inhaled corticosteroids);
4. Any active infection requiring systemic therapy by intravenous infusion within 14
days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis
infection, or active pulmonary tuberculosis.
5. History of hypersensitivity reactions to murine protein-containing products, or
macromolecular biopharmaceuticals such as antibodies or cytokines;
6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.)
within 1 years after enrollment;
7. Women who are pregnant (urine/blood pregnancy test positive) or lactating;
8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering
from mental illness;
10. Known alcohol dependence or drug dependence; 11. According to the investigator's
judgment, the patient has other unsuitable grouping conditions.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Recruiting
Contact:
Last name:
Liangding Hu, Ph.D
Phone:
+86-010-6694-7171
Email:
huliangding@sohu.com
Contact backup:
Last name:
Yao Sun, Ph.D
Phone:
+86-010-6694-7172
Email:
suny320@126.com
Start date:
October 1, 2022
Completion date:
October 30, 2024
Lead sponsor:
Agency:
Affiliated Hospital to Academy of Military Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Beijing JD Biotech Co. LTD.
Agency class:
Other
Source:
Affiliated Hospital to Academy of Military Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05574608
