Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies
|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: NCT03638206|
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia Lymphoma Myeloid Leukemia Multiple Myeloma Hepatoma Gastric Cancer Pancreatic Cancer Mesothelioma Colorectal Cancer Esophagus Cancer Lung Cancer Glioma Melanoma Synovial Sarcoma Ovarian Cancer Renal Carcinoma||Biological: CAR-T cell immunotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Immunotherapy With Multi-target Gene-modified CAR-T/TCR-T Cell for Malignancies|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2023|
Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.
Biological: CAR-T cell immunotherapy
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.
- Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 [ Time Frame: 60 months ]Safety evaluation
- Clinical response [ Time Frame: 60 months ]Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging.
- CAR-T cells testing [ Time Frame: 60 months ]The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
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): NCT03638206
|Contact: ZhongHua Yangfirstname.lastname@example.org|
|The First Affiliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Yi Zhang, MD, PhD 86-15138928971 email@example.com|