CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy
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|ClinicalTrials.gov Identifier: NCT03068416|
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|B-cell Leukemia B-Cell Lymphoma||Biological: CAR T cells||Phase 2|
Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After the second infusion patients will be subjected to immunomodulatory treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
- Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events.
Weekly for the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Tumor response, CAR T cell persistence and immunological profile
- Determination of tumor size and the tumor marker CD19.
- Determination of the levels of circulating B cells.
- Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies.
- Determination of activation markers on CAR T cells such as CD107a.
- Determination of the presence of immunological markers in blood and biopsies.
At 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy - a Phase II Trial.|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||August 19, 2021|
|Actual Study Completion Date :||August 19, 2021|
Experimental: CAR T cells
Autologous 3rd generation CD19-targeting CAR T cells
Biological: CAR T cells
Autologous CD19-targeting, 3rd generation CAR T cells
- Safety [ Time Frame: 24 months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Tumor response [ Time Frame: 24 months. ]Determination of tumor size
- B cell levels [ Time Frame: 24 months ]Determination of circulating CD19+ B cells
- CAR T cell persistence [ Time Frame: 24 months ]Determination of the level of CAR T cells
- Immunological profile [ Time Frame: 24 months ]Determination of frequencies of immune cells in patient blood and tissues
- Cytokine profile [ Time Frame: 24 months ]Determination of cytokine profile in patient 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): NCT03068416
|Uppsala University Hospital, Dept of Oncology|
|Uppsala, Sweden, 75185|
|Principal Investigator:||Gunilla Enblad, MD, PhD||Uppsala University Hospital, Dept of Oncology|