- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05008575
Anti-CD33 CAR NK Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
December 22, 2021 updated by: Xi Zhang, MD, Xinqiao Hospital of Chongqing
Phase I Study to Evaluate the Safety and Effectiveness of Anti-CD33 CAR NK Cell Therapy in Relapsed/Refractory Acute Myeloid Leukemia
CAR technology has been used in T cell therapy and gets great success in treating hematological diseases.
Following models of CAR T cells, CAR NK cell therapy has been one hot point.
For myeloid malignancies, CD33 is widely expressed.
Targeting CD33 surface antigens by CAR NK cells provides an off-the-shelf immune cell therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
27
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: ruihao huang, MD
- Phone Number: +86 18984398751
- Email: 1169731117@qq.com
Study Contact Backup
- Name: Xi Zhang, MD/PhD
- Phone Number: +86 13808310064
- Email: zhangxxi@sina.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400037
- Recruiting
- Department of Hematology, Xinqiao Hospital
-
Contact:
- Xi Zhang, MD/PhD
- Phone Number: +86 13808310064
- Email: zhangxxi@sina.com
-
Contact:
- Ruihao Huang, PhD candidate
- Phone Number: +86 18984398751
- Email: 1169731117@qq.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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ECOG performance status score ≤ 2.
- Life expectancy ≥ 12 weeks from the time of enrollment.
- Disease status at the time of enrollment: -Patients with AML (except M3) who have not achieved complete remission after standard chemotherapy regimens; -Not suitable or unconditional for allogeneic hematopoietic stem cell transplantation; -Patients with recurrent acute myeloid leukemia after autologous hematopoietic stem cell transplantation without active graft-versus-host disease (GVHD).
- CD33 expression must be detected on greater than 50% of the malignant cells by immunohistochemistry or greater than 80% by flow cytometry.
- Adequate main organ function as assessed by the following laboratory requirements: creatinine ≤ 2.5 × upper limit of normal, cardiac ejection fraction ≥ 40%, oxygen saturation ≥ 90%, total bilirubin ≤ 3 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, Hgb≥80g/L.
- Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (immune suppressive drugs or corticosteroid treatment) within 4 weeks of screening.
- Women of child-bearing age must have evidence of negative pregnancy test.
- Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.
- After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
- All participants must have the ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded.
- Active acute or chronic GVHD or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
- Have been diagnosed with or treated other malignant tumors other than AML within 5 years before screening, except for the following conditions: participants with adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer; or received radical treatment Local prostate cancer, ductal carcinoma in situ.
- There are serious systemic diseases: New York Heart Association (NYHA) stage III or IV congestive heart failure; cerebrovascular accident or myocardial infarction or hemodynamic instability caused by arrhythmia within 6 months before signing the informed consent; impaired cardiac function (LVEF<50%) assessed by echocardiographic scan.
- Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
- Pregnant or lactating women.
- Subjects with radiologically-detected CNS chloromas or CNS 3 disease (presence of ≥ 5/μL white blood cells (WBCs) in cerebral spinal fluid (CSF) and cytospin positive for blasts [in the absence of a traumatic lumbar puncture] and/or clinical signs of CNS leukemia such as a cranial nerve palsy from active disease). Subjects with adequately treated CNS leukemia are eligible.
- Human immunodeficiency virus (HIV) seropositivity; hepatitis B surface antigen is positive or HBV DNA is higher than the detection limit of the analysis method; hepatitis C antibody is positive or HCV RNA is higher than the detection limit of the analysis method; syphilis antibody and syphilis rapid plasma reagin are positive; CMV DNA is positive.
- Patients who suffer from allergies for any cytokines or antibodies.
- Contraindications for fludarabine or cyclophosphamide treatment.
- Receiving corticosteroids at >20 mg daily prednisone dose or equivalent.
- Drug abuse and addiction.
- History of mental disorders.
- Other patients that researchers considered unsuitable for inclusion.
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: antiCD33 CAR NK cells
After preconditioning with chemotherapy, the antiCD33 CAR NK cells will be evaluated
|
recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline.
recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline.
6×10^8, 12×10^8, 18×10^8/KG Treatment follows a lymphodepletion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Remission Rate (ORR)
Time Frame: 4 weeks after infusion
|
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CRi), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
|
4 weeks after infusion
|
incidence of participants with dose limiting toxicity (DLT)
Time Frame: within 4 weeks after infusion
|
To characterize the safety, tolerability of Anti-CD33 CAR NK cells
|
within 4 weeks after infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS)
Time Frame: up to 2 years after infusion
|
up to 2 years after infusion
|
Overall Response Rate (ORR)
Time Frame: up to 2 years after infusion
|
up to 2 years after infusion
|
Overall survival(OS)
Time Frame: up to 2 years after infusion
|
up to 2 years after infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: xi zhang, MD/PhD, Department of Hematology, Xinqiao Hospital
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 (Actual)
December 23, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
August 14, 2021
First Submitted That Met QC Criteria
August 16, 2021
First Posted (Actual)
August 17, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2022
Last Update Submitted That Met QC Criteria
December 22, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
Other Study ID Numbers
- CD33 CAR NK-AML
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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 Leukemia, Myeloid, Acute
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Jacqueline Garcia, MDEli Lilly and CompanyCompletedCombination Merestinib and LY2874455 for Patients With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed Adult Acute Myeloid Leukemia | Refractory Adult Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
Massachusetts General HospitalExelixisCompletedRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
University of NebraskaNational Cancer Institute (NCI)Active, not recruitingSecondary Acute Myeloid Leukemia | Therapy-Related Acute Myeloid Leukemia | Adult Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
Clinical Trials on Fludarabine
-
National Institute of Arthritis and Musculoskeletal...CompletedPsoriasis | Arthritis, PsoriaticUnited States
-
Nantes University HospitalCyceronNot yet recruiting
-
Emory UniversityCompletedSickle Cell Disease | Bone Marrow TransplantationUnited States
-
Naoyuki G. Saito, M.D., Ph.D.WithdrawnAcute Myeloid Leukemia | Myelodysplastic Syndromes | Chronic Myeloid Leukemia | Acute Lymphocytic LeukemiaUnited States
-
National Institute of Arthritis and Musculoskeletal...CompletedSystemic Lupus Erythematosus | Glomerulonephritis | Lupus NephritisUnited States
-
University Hospital, CaenCNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, FranceCompletedUntreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma PatientsFrance
-
University of Illinois at ChicagoCompletedAcute Myeloid Leukemia | Polycythemia Vera | Multiple Myeloma | Myelofibrosis | Acute Leukemia | Chronic Myelogenous Leukemia | Aplastic Anemia | Myeloproliferative Disorder | Hodgkin's Disease | Malignant Lymphoma | Lymphocytic LeukemiaUnited States
-
Massachusetts General HospitalTerminatedMultiple Myeloma | Hodgkin Disease | Non Hodgkin's LymphomaUnited States
-
German CLL Study GroupCompletedAnemia | Chronic Lymphocytic LeukemiaGermany
-
Zhujiang HospitalFirst Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern... and other collaboratorsUnknownLeukemia Relapse | Chronic Graft-versus-host-disease