The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.
Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The T cells are isolated from the PBMC, transduced with a lentivirus to express the CD19 CAR as well as a truncated EGFR that has no signaling capacity (noted EGFRt) and expanded in vitro and then administered to subjects. Subjects will have blood tests to assess safety and efficacy, and persistence of the CD19 CAR-T cells on week 4 after their last infusion. Following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, MRD and persistence of CD19 CAR-T. Some subjects will receive cetuximab for ablation of the genetically modified T cells. Criteria to receive cetuximab include acute toxicities that are life threatening.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).
Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).
CD19 CAR-T cells will be administered after completion of the chemotherapy.
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGsafety as assessed by the occurence of study related adverse events
number of participants with adverse events
Time frame: 30 days
anti-tumor responses of CD19 CAR-T cells
Time frame: 1 year
Persistence of the CD19 CAR+ T cells
determine duration of in vivo survival of CD19 CAR-T cells
Time frame: 1 year
Number of participants who have T cells ablated with cetuximab
The efficacy of cetuximab to ablate the T cells will be measured by loss of detection of T cells and any associated toxicities as well as facilitating B cell recovery.
Time frame: 1 year
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