B-cell Acute Lymphocytic Leukemia Clinical Trial
Official title:
A Study of CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-cell Acute Lymphoblastic Leukemia
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03064269 -
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
|
Phase 1 | |
| Not yet recruiting |
NCT06287229 -
Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab
|
Phase 1/Phase 2 |