- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05987696
Natural Killer(NK) Cell Therapy in Acute Myeloid Leukemia
August 4, 2023 updated by: Institute of Hematology & Blood Diseases Hospital
Phase I Study to Evaluate the Safety and Efficacy of NK Cell Therapy in Acute Myeloid Leukemia (AML).
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).
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
102
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianxiang Wang
- Phone Number: 022-23909120
- Email: wangjx@ihcams.ac.cn
Study Contact Backup
- Name: Ying Wang, M.D.
- Phone Number: 022-23909278
- Email: wangying1@ihcams.ac.cn
Study Locations
-
-
-
Tianjin, China
- Institute of Hematology & Blood Diseases Hospital
-
Contact:
- Jianxiang Wang
- Phone Number: 022-23909120
- Email: wangjx@ihcams.ac.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form (ICF).
- ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
- Diagnosis of r/r AML (Cohort 1 and 2) or AML MRD (Cohort 3).
- Cohort 1: Both CLL1 and CD33 expression are positive in AML blasts; Cohort 2: The expression of CD33 in AML blast is positive.
Adequate organ and marrow function, as defined below:
- Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min;
- Total bilirubin (TBIL) ≤ 2 x the ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN;
- Females of childbearing potential must have a negative serum pregnancy test.
- Donor specific antibody (DSA) is negative: MFI <= 2000.
Exclusion Criteria:
- Allergic to drug used in this study.
Subjects received any antitumor therapy as follows, prior to first NK infusion:
- Systemic steroid therapy within 3 days (except physiological replacement therapy);
- Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less;
- Radiotherapy within 4 weeks;
- Donor lymphocyte infusion within 6 weeks;
- Intrathecal treatment within 1 week;
- CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;
- History of allogeneic stem cell transplantation.
- 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.
- Active central nervous system Leukemia.
- Acute Promyelocytic Leukemia (APL).
- 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.
- Active autoimmune diseases.
- History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc.
Serious cardiovascular and cerebrovascular diseases:
- Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms;
- 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;
- New York Heart Association (NYHA) class II or above congestive heart failure or left ventricular ejection fraction (LVEF) <50% in color Doppler echocardiography;
- Hypertension that cannot be controlled by drug.
- Active pulmonary infection; SpO2 ≤90%; Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease.
- Uncontrolled bacterial, fungal, or viral infection. Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection.
- History of substance abuse.
- Toxicity induced by previous therapy not recovered to ≤ grade 2(NCI-CTCAE v5.0).
- Large surgical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy.
- Pregnant/breastfeeding women.
- Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CD33/CLL1 dual CAR-NK cell
CLL1/CD33 dual CAR-NK cell therapy in Adult subjects with r/r AML
|
Lympho-conditioning Agent
Lympho-conditioning Agent
Lympho-conditioning Agent
NK cell therapy
|
Experimental: CD33 CAR-NK cell
CD33 CAR-NK cell therapy in Adult subjects with r/r AML
|
Lympho-conditioning Agent
Lympho-conditioning Agent
Lympho-conditioning Agent
NK cell therapy
|
Experimental: super NK cell
super NK cell therapy in Adult subjects with AML MRD
|
Lympho-conditioning Agent
Lympho-conditioning Agent
Lympho-conditioning Agent
NK cell therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 28 Days from first dose of iPSC NK cell infusion
|
28 Days from first dose of iPSC NK cell infusion
|
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time Frame: 28 Days from first dose of iPSC NK cell infusion
|
28 Days from first dose of iPSC NK cell infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate(ORR)
Time Frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
|
Up to approximately 2 years after last dose of iPSC NK cell infusion
|
|
MRD negative rate
Time Frame: 28 Days from first dose of iPSC NK cell infusion
|
28 Days from first dose of iPSC NK cell infusion
|
|
Event-free survival
Time Frame: Up to approximately 2 years after last dose of iPSC NK cell infusion]
|
Up to approximately 2 years after last dose of iPSC NK cell infusion]
|
|
Relapse-free survival
Time Frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
|
Up to approximately 2 years after last dose of iPSC NK cell infusion
|
|
Overall survival (OS)
Time Frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
|
Up to approximately 2 years after last dose of iPSC NK cell infusion
|
|
Determination of the pharmacokinetics (PK) of iPSC NK cells in peripheral blood
Time Frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
|
The PK of iPSC NK in peripheral blood will be reported as the relative percentage of product DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points.
|
Up to approximately 2 years after last dose of iPSC NK cell infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 10, 2023
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
July 24, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplastic Processes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Neoplasm, Residual
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
- Cytarabine
Other Study ID Numbers
- QH-TJ-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Minimal Residual Disease
-
Nanfang Hospital of Southern Medical UniversityUnknownMinimal Residual Disease,Acute Leukemia, Hypomethylating Agents, Donor Lymphocyte Infusion, Allogeneic Hematopoietic Cell TransplantationChina
-
University of LeicesterActive, not recruitingCancerUnited Kingdom
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)WithdrawnAcute Myeloid Leukemia | Minimal Residual Disease NegativityUnited States
-
Karolinska University HospitalMedical University of Graz; Aarhus University Hospital; Centre Hospitalier Universitaire... and other collaboratorsEnrolling by invitationPancreatic AdenocarcinomaSweden
-
University Hospital, Clermont-FerrandUnknownMinimal Residual Disease | Fertility PreservationFrance
-
AmgenTerminatedMyelodysplastic Syndrome | Relapsed/Refractory AML | Minimal Residual Disease Positive AMLUnited States, Canada, Germany, Netherlands
-
Institute of Hematology & Blood Diseases HospitalRecruiting
-
University Hospital, Clermont-FerrandUnknownMinimal Residual Disease | Fertility PreservationFrance
-
Guangdong Provincial People's HospitalShenzhen Chipscreen Biosciences Co.LtdRecruitingMinimal Residual Disease | AML, AdultChina
-
Xianmin Song, MDRecruiting
Clinical Trials on Cyclophosphamid
-
Peking University People's HospitalRecruiting
-
Priv.-Doz. Dr. med. Joachim RomCompletedEpithelial Ovarian CancerGermany
-
Assiut UniversityActive, not recruiting
-
St. Petersburg State Pavlov Medical UniversityRecruitingMyelodysplastic Syndromes | Chronic Myeloid Leukemia | Myeloproliferative Neoplasm | Myeloid Leukemia, AcuteRussian Federation
-
Beijing 302 HospitalNot yet recruitingHematological Malignancies | Graft-versus-host Disease
-
Second Affiliated Hospital, School of Medicine,...Carbiogene Therapeutics Co. Ltd.RecruitingRelapsed or Refractory Multiple MyelomaChina
-
UNC Lineberger Comprehensive Cancer CenterUniversity Cancer Research Fund at Lineberger Comprehensive Cancer CenterRecruiting
-
University of LiegeBelgian Hematological SocietyRecruitingMyelodysplastic Syndromes | Multiple Myeloma | Hodgkin Lymphoma | Non Hodgkin Lymphoma | Myeloproliferative Disorder | Chronic Lymphoid Leukemia | Acute Myeloid Leukemia in Remission | Myeloproliferative Syndrome | Chronic Myeloid Leukemia in Remission | Acute Lymphoid Leukemia in RemissionBelgium
-
Zhejiang UniversityHangzhou Qihan Biotech Co.,Ltd.RecruitingB-cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaChina
-
Ironshore Pharmaceuticals and Development, IncCompletedAttention-Deficit Hyperactivity Disorder (ADHD)United States