CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid 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: NCT03121625|
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: Autologous CAR-T||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies|
|Actual Study Start Date :||December 26, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2021|
Experimental: Autologous CAR-T cells
Patients will be be treated with autologous CAR-T cells.
Biological: Autologous CAR-T
Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.
- Tumor load [ Time Frame: Up to 24 months ]Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
- CAR T cell persistence [ Time Frame: Up to 24 months] ]CAR T cell persistence will be quantified with flow cytometry and qPCR
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): NCT03121625
|Contact: Jianqiang Li, PhD & MDemail@example.com|
|Hematology Department, Hebei Medical University Fourth Hospital||Recruiting|
|Shijiazhuang, Hebei, China, 050000|
|Contact: Lihong Liu, PhD & MD +8613831177920 firstname.lastname@example.org|
|Contact: PhD & MD|
|Principal Investigator: Lihong Liu, PhD & MD|
|Sub-Investigator: Jianqiang Li, PhD & MD|
|Principal Investigator:||Lihong Liu, PhD & MD||Hebei Medical University Fourth Hospital|