Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02842138|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|B-cell Lymphoma||Biological: autologous anti-CD19 CAR T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting CD19 in Patients With Relapsed or Refractory B-cell Lymphoma|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||February 28, 2018|
|Estimated Study Completion Date :||August 2019|
Experimental: CD19 CAR T cells
A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.
Biological: autologous anti-CD19 CAR T cells
Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%).
- Number of patients with adverse events [ Time Frame: 2 years ]
- Treatment response rate of anti-CD19 CAR T cell infusion [ Time Frame: 4 weeks ]Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on standardized response criteria for malignant lymphoma (Cheson BD, JCO, 2007).
- overall survival rate of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]
- progression-free survival of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]
- Persistence of CAR T cells in patients [ Time Frame: 2 years ]
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): NCT02842138
|Peking University Cancer Hospital|
|Beijing, China, 100142|
|Principal Investigator:||Jun Zhu, MD||Beijing Cancer Hospital|