To hear about similar clinical trials, please enter your email below
Trial Title:
Natural Killer(NK) Cell Therapy in Acute Myeloid Leukemia
NCT ID:
NCT05987696
Condition:
AML, Adult
Minimal Residual Disease
Conditions: Official terms:
Leukemia, Myeloid, Acute
Neoplasm, Residual
Cytarabine
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CD33/CLL1 dual CAR-NK cell
Description:
NK cell therapy
Arm group label:
CD33/CLL1 dual CAR-NK cell
Intervention type:
Drug
Intervention name:
Cyclophosphamid
Description:
Lympho-conditioning Agent
Arm group label:
CD33 CAR-NK cell
Arm group label:
CD33/CLL1 dual CAR-NK cell
Arm group label:
super NK cell
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Lympho-conditioning Agent
Arm group label:
CD33 CAR-NK cell
Arm group label:
CD33/CLL1 dual CAR-NK cell
Arm group label:
super NK cell
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Lympho-conditioning Agent
Arm group label:
CD33 CAR-NK cell
Arm group label:
CD33/CLL1 dual CAR-NK cell
Arm group label:
super NK cell
Intervention type:
Drug
Intervention name:
CD33 CAR-NK cell
Description:
NK cell therapy
Arm group label:
CD33 CAR-NK cell
Intervention type:
Drug
Intervention name:
super NK cell
Description:
NK cell therapy
Arm group label:
super NK cell
Summary:
This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the
safety, tolerability and preliminary efficacy of iPSC NK cells in patients with
relapsed/refractory AML or AML Minimal Residual Disease (MRD).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form (ICF).
2. ≥18 years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy
greater than 12 weeks.
4. Diagnosis of r/r AML (Cohort 1 and 2) or AML MRD (Cohort 3).
5. Cohort 1: Both CLL1 and CD33 expression are positive in AML blasts; Cohort 2: The
expression of CD33 in AML blast is positive.
6. Adequate organ and marrow function, as defined below:
1. Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance
(Cockcroft-Gault formula) ≥ 50 mL/min;
2. Total bilirubin (TBIL) ≤ 2 x the ULN;
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
4. International normalized ratio (INR) and activated partial thromboplastin time
(aPTT) ≤ 1.5 x ULN;
7. Females of childbearing potential must have a negative serum pregnancy test.
8. Donor specific antibody (DSA) is negative: MFI <= 2000.
Exclusion Criteria:
1. Allergic to drug used in this study.
2. Subjects received any antitumor therapy as follows, prior to first NK infusion:
1. Systemic steroid therapy within 3 days (except physiological replacement
therapy);
2. Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever
is less;
3. Radiotherapy within 4 weeks;
4. Donor lymphocyte infusion within 6 weeks;
5. Intrathecal treatment within 1 week;
6. CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy
product within 6 months;
3. History of allogeneic stem cell transplantation.
4. Received the vaccine within 4 weeks prior to the first infusion and/or expected to
require vaccination from the study period to 12 weeks after the last infusion.
5. Active central nervous system Leukemia.
6. Acute Promyelocytic Leukemia (APL).
7. History of other malignant tumors, except for those who have achieved complete
remission more than 5 years after radical treatment without any signs of recurrence.
8. Active autoimmune diseases.
9. History of central nervous system disease or meningeal involvement such as epilepsy,
paralysis, aphasia, stroke, etc.
10. Serious cardiovascular and cerebrovascular diseases:
1. Severe heart rhythm or conduction abnormalities, corrected QT interval
(QTc)≥480 ms;
2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke,
or other grade 3 or higher cardiovascular and cerebrovascular events within 6
months prior to first infusion;
3. New York Heart Association (NYHA) class II or above congestive heart failure or
left ventricular ejection fraction (LVEF) <50% in color Doppler
echocardiography;
4. Hypertension that cannot be controlled by drug.
11. Active pulmonary infection; SpO2 ≤90%; Pulmonary embolism, chronic obstructive
pulmonary disease, or interstitial lung disease.
12. Uncontrolled bacterial, fungal, or viral infection. Known HIV infection, active
Hepatitis B (HBV) or Hepatitis C (HCV) infection.
13. History of substance abuse.
14. Toxicity induced by previous therapy not recovered to ≤ grade 2(NCI-CTCAE v5.0).
15. Large surgical treatment within 4 weeks prior to first infusion, not including
diagnostic biopsy.
16. Pregnant/breastfeeding women.
17. Investigator-assessed presence of any medical or social issues that are likely to
interfere with study conduct or may cause increased risk to subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Jianxiang Wang
Phone:
022-23909120
Email:
wangjx@ihcams.ac.cn
Start date:
August 10, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
Hangzhou Qihan Biotech Co.,Ltd.
Agency class:
Industry
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05987696
