CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas (CART30)
|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: NCT02259556|
Recruitment Status : Recruiting
First Posted : October 8, 2014
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin's Lymphoma Non-Hodgkin's Lymphoma||Biological: CART30||Phase 1 Phase 2|
When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.
Extra blood will be drawn to measure the persistence of CART30 in vivo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2029|
Experimental: anti-CD30 CAR T cells
Patients receive CART30 cell infusions with an escalation dose.
Cells will be infused 1 day after the completion of conditioning regimen.
Other Name: anti-CD30 CAR T cells
- Occurrence of related adverse events [ Time Frame: untill week 24 ]
- Anti-tumor response to CART30 cell infusions [ Time Frame: Up to 24 weeks ]Evaluated mainly by computed tomography scanning
- in vivo existence of CART30 [ Time Frame: 1 year ]Measure mainly by the changes of CAR molecule levels in blood
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): NCT02259556
|Contact: Weidong Han, Ph.Dfirstname.lastname@example.org|
|Contact: Quanshun Wang, Ph.Demail@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, Ph.D 86-10-66937463 firstname.lastname@example.org|
|Contact: Quanshun Wang, Ph.D 86-10-66939486 email@example.com|
|Study Chair:||Weidong Han, Ph.D||Chinese PLA General Hospital|