CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
|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: NCT02132624|
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma B Cell Leukemia||Biological: Autologous 3rd generation CD19-targeting CAR T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||May 31, 2017|
|Actual Study Completion Date :||May 31, 2017|
Experimental: CAR T cells
Autologous 3rd generation CD19-targeting CAR T cells
Biological: Autologous 3rd generation CD19-targeting CAR T cells
Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.
- CAR T cell persistence [ Time Frame: At week 1 and 5, there after every 3 months post treatment up to 24 months ]Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.
- Tumor load [ Time Frame: Every 3 months post treatment up to 24 months ]Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
- B cell number and immunoglobulins [ Time Frame: Weekly for 5 weeks, then every 3 months post treatment up to 24 months ]Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics
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): NCT02132624
|Uppsala University Hospital, Dept of Oncology|
|Uppsala, Sweden, 75185|
|Study Director:||Angelica Loskog, PhD||Uppsala University|
|Principal Investigator:||Gunilla Enblad, MD, PhD||Uppsala University Hospital|
|Principal Investigator:||Hans Hagberg, MD, PhD||Uppsala University Hospital|