- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744440
Safety and Efficacy of Allogenic NK Cells in Combination With Chemotherapy in the Treatment of r/r AML After Allo-HSCT
February 23, 2023 updated by: Kai Lin Xu,MD, Xuzhou Medical University
Early Clinical Study of Allogenic NK Cells (JD002) in Combination With Chemotherapy in the Treatment of Relapsed or Refractory(r/r) Acute Myeloid Leukemia(AML) After Allo-HSCT
This is an open label, single-arm, Phase I study to evaluate the efficacy and safety of allogenic natural killer(NK) cells in subjects with refractory or relapsed AML after allogeneic hematopoietic stem cell transplantation(allo-HSCT).
A leukapheresis procedure will be performed to manufacture NK cells.
Prior to allogenic NK cells infusion subjects will receive chemotherapy with azacitidine.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This open label, single-arm, Phase I study aims to evaluate the efficacy and safety of allogenic NK cells in subjects with refractory or relapsed AML after allo-HSCT.
A leukapheresis procedure will be performed to manufacture NK cells.
Prior to allogenic cells infusion subjects will receive chemotherapy with azacitidine.
After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable dose(MTD) and recommended phase 2 dose(rp2d) were confirmed.
To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Early 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: Junnian Zheng, M.D., Ph.D
Study Locations
-
-
Jiangsu
-
Xuzhou, Jiangsu, China, 221000
- Recruiting
- The Affiliated Hospital of Xuzhou Medical University
-
Contact:
- Kailin Xu, M.D,Ph.D
- Phone Number: 15162166166
- Email: lihmd@163.com
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age18-75years old, no gender or race;
- Expected survival is more than 3 months;
- Eastern Cooperative Oncology Group (ECOG) score 0-2 points;
- Diagnosed as AML in accordance with the criteria from Chinese guidelines for the diagnosis and treatment of adult AML (not acute promyelocytic leukemia (APL))(2021) and The new edition of the 2016 World Health Organization (WHO) classification system for tumors of the hematopoietic and lymphoid tissues;
- Diagnosed as relapsed AML;
- Measurable lesions meets at least one of the following requirements during screening: (1) Persistent positive MRD or relapse with positive minimal residual disease (MRD) in the bone marrow(BM); (2) Appearance of leukemic blasts in the peripheral blood; (3) ≥5% blasts in the BM; (4) extramedullary relapse;
- Within 3 days prior to initial treatment, the organ functions meet the following requirements: (1) complete blood cell count: a. Absolute neutrophil counts ≥1.0×109/L and not treated with granulocyte colony stimulating factor(G-CSF) within 7 days; b.Hemoglobin ≥6g/dL(red blood cell; transfusion are permitted); c.Platelet ≥50×109/L(platelet transfusion are permitted); (2) Liver function: alanine transaminase (ALT)/ aspartate aminotransferase(AST) ≤ 3× times upper normal limit(ULN), total bilirubin ≤ 2 times ULN (direct bilirubin ≥ 1.5 times ULN is acceptable for subjects with Gilbert-Meulengracht syndrome); (3)Coagulation function: International standardized ratio (INR) or activated partial thrombin time (APTT) ≤1.5 times ULN; (4)Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30ml/min; (5)Corrected serum calcium ≤14mg/dL (≤3.5mmol/L) or free calcium ≥6.5mg/dL(≥1.6mmol/L); (6)Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
- Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
- Confirmed APL;
- ≥2 grade persistent nonhematologic toxicity of associated with prior treatment;
- Patients with grade II-IV graft-versus-host disease (GVHD) requiring the use of immunosuppressive agents ;
- Systemic steroid therapy exceeding the equivalent of ≥30mg/kg/day of prednisone within 48 hours prior to the first dose of study drug or other immunosuppressive therapies (except for topical and inhaled glucocorticoid therapy, or short-term prophylactic therapy with glucocorticoid) ;
- Severe cardiovascular and cerebrovascular diseases, including: (1) Some cardiovascular and cerebrovascular diseases (such as congestive heart failure, acute myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism, etc.) occur within 6 months prior to the first dose of study drug; (2)New York Heart Association (NYHA) Class ≥3 or uncontrolled malignant arrhythmias; (3)The researchers assessed that the subjects with other cardiovascular and cerebrovascular diseases are not suitable for the study;
- Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), syphilis infection, or active pulmonary tuberculosis;
- History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
- Previous or next organ transplant (except for HCT);
- Women who are pregnant (urine/blood pregnancy test positive) or lactating;
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 6 months after enrollment;
- Any unstable condition potentially imperiling patient safety and compliance;
- Known alcohol dependence or drug dependence;
- According to the investigator's judgment, the patient has other unsuitable grouping conditions.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: allogenic NK cells
Enrolled patients will receive prespecified dose of allogenic NK cells
|
The relapsed/refractory AML after allo-HSCT patients will receive allogenic NK cells infusion up to 2 dose levels (1x10^7/kg, 5x10^7/kg) after chemotherapy with azacitidine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicities
Time Frame: 1 month
|
Adverse events assessed according to NCI-CTCAE v5.0 criteria
|
1 month
|
Objective Response Rate(ORR)
Time Frame: 3 months
|
Assessment of ORR (ORR = complete response(CR) + CRi(CR incomplete blood count recovery)+ PR(partial response)) at 3 months of treatment
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival(OS)
Time Frame: Month 6, 12, 18 and 24
|
Assessment of OS at month 6, 12, 18 and 24
|
Month 6, 12, 18 and 24
|
Progression free survival(PFS) Assessment of PFS at month 6,12 Progression free survival(PFS)
Time Frame: Month 6,12
|
Assessment of PFS at month 6,12
|
Month 6,12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kailin Xu, M.D., Ph.D., Xuzhou Medical University
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 (Anticipated)
March 1, 2023
Primary Completion (Anticipated)
May 1, 2025
Study Completion (Anticipated)
May 1, 2025
Study Registration Dates
First Submitted
February 11, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Estimate)
February 27, 2023
Study Record Updates
Last Update Posted (Estimate)
February 27, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XYFY2022-KL282-01
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.
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