CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02742727|
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell Prolymphocytic Leukemia T-cell Large Granular Lymphocytic Leukemia Peripheral T-cell Lymphoma, NOS Angioimmunoblastic T-cell Lymphoma Extranodal NK/T-cell Lymphoma, Nasal Type Enteropathy-type Intestinal T-cell Lymphoma Hepatosplenic T-cell Lymphoma||Biological: anti-CD7 CAR-pNK cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chimeric Antigen Receptor-Modified pNK Cells for CD7 Positive Relapsed or Refractory Leukemia and Lymphoma|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: CAR-pNK Cell immunotherapy
Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD7 antigen by infusion.
Biological: anti-CD7 CAR-pNK cells
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD7 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD7.
Other Name: chimeric antigen receptor NK cells with specificity for CD7
- Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells [ Time Frame: 2 years ]Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
- Clinical response to CD7 CAR-pNK cell infusions [ Time Frame: Safety follow-up is 100 days from last CAR-pNK infusion ]Patients with measurable disease will be assessed for the response of their disease to CD7 CAR-pNK cell treatment.
- Determine the existence of CD7-CAR-pNK in vivo [ Time Frame: 1 year ]
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): NCT02742727
|Contact: Lin Yang, Ph.D.||firstname.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|
|Principal Investigator:||Lin Yang, Ph.D.||PersonGen BioTherapeutics (Suzhou) Co., Ltd.|