Spots Global Cancer Trial Database for CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
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Trial Identification
Brief Title: CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
Official Title: CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
Study ID: NCT02132624
Interventions
Study Description
Brief Summary: Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. 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 T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Uppsala University Hospital, Dept of Oncology, Uppsala, , Sweden
Contact Details
Name: Angelica Loskog, PhD
Affiliation: Uppsala University
Role: STUDY_DIRECTOR
Name: Gunilla Enblad, MD, PhD
Affiliation: Uppsala University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Hans Hagberg, MD, PhD
Affiliation: Uppsala University Hospital
Role: PRINCIPAL_INVESTIGATOR
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