CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML
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|ClinicalTrials.gov Identifier: NCT02944162|
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Acute Myeloid Leukemia Acute Myeloid Leukemia With Maturation Acute Myeloid Leukemia Without Maturation ANLL||Biological: anti-CD33 CAR-NK cells||Phase 1 Phase 2|
Determine the safety and feasibility of the chimeric antigen receptor NK92 cells transduced with the anti-CD33 vector (referred to as anti-CD33 CAR-NK cells).
I. For patients with detectable disease, measure anti-leukemia response due to anti-CD33 CAR-NK cell infusions.
II. For patients with stored or accessible leukemia blasts, determine leukemia cell killing by anti-CD33 CAR-NK in vitro.
III. Determine if cellular or humoral host immunity develops against the murine anti-CD33.
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-CD33 CAR-NK (coupled with CD28, CD137 and CD3 zeta signalling domains) vector-transduced NK92 cell line on days 0,3, and 5 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Investigation of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified NK92 Cells in Relapsed and/or Refractory Acute Myeloid Leukemias|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2018|
Experimental: CAR-NK Cell immunotherapy
Enrolled patients will receive CAR-NK cells immunotherapy with a novel specific chimeric antigen receptor targeting CD33 antigen by infusion.
Biological: anti-CD33 CAR-NK cells
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD33 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD33.
Other Name: Chimeric antigen receptor NK92 cells with specificity for CD33
- Adverse events attributed to the administration of the anti-CD33 CAR-NK cells [ Time Frame: One year ]Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment
- Objective Response Rate [ Time Frame: Up to one year ]Anti-leukemia responses to anti-CD33 CAR-NK cell infusions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944162
|Contact: Lin Yang, Ph.Dfirstname.lastname@example.org|
|PersonGen BioTherapeutics (Suzhou) Co., Ltd.||Recruiting|
|Suzhou, Jiangsu, China, 215123|
|Contact: Lin Yang, Ph.D 86-512-65922190 email@example.com|
|Principal Investigator: Yangyi Bao, MD|
|Principal Investigator: Xiang Sun, MD|
|Principal Investigator: Lin Yang, Ph.D|