Evaluation of 4th Generation Safety-designed CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas (4SCAR19273)
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|ClinicalTrials.gov Identifier: NCT02247609|
Recruitment Status : Unknown
Verified January 2014 by Jun Zhu, Peking University.
Recruitment status was: Recruiting
First Posted : September 25, 2014
Last Update Posted : October 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|B-cell Lymphomas||Genetic: Anti-CD19 CAR T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2017|
Experimental: CAR T cells
Autologous 4th generation anti-CD19-CAR T cells
Genetic: Anti-CD19 CAR T cells
Autologous 4th generation withdrawable lentiviral-transduced anti-CD19-CAR T cells
Other Name: 19273-4SCAR
- Number of patients with adverse events. [ Time Frame: 2 years. ]Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
- Survival time of Anti-CD19 CAR T cells in vivo. [ Time Frame: 2 years. ]Measure the survival of 4th generation CAR T cells transduced with the anti-CD19 lentiviral vector.
- Response rates to the 4th generation CAR T cells. [ Time Frame: 2 years. ]Describe the response rates of patients treated with 4th generation CAR T cells, including partial remission (PR), complete remission (CR), stable disease (SD) and progressive disease (PD).
- Survival time of the patients. [ Time Frame: 2 years. ]Evaluate the survival time of the patients treated with the 4th generation CAR T cells, including progression free survival (PFS) and overall survival (OS).
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): NCT02247609
|Contact: Jun Zhu, MDfirstname.lastname@example.org|
|Peking University Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Jun Zhu, MD +86-10-88196596 email@example.com|
|Principal Investigator: Jun Zhu, MD|
|Principal Investigator:||Jun Zhu, MD||Peking University Cancer Hospital & Institute|