This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells.
This study will utilize a staggered enrollment design with a safety observation period.
Subjects aged ≥ 18 years.
Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)/Richter's syndrome. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.
Subjects who have relapsed or refractory disease after failing at least 2 or more prior lines of therapy.
ECOG Performance Status ≤ 2.
Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.
Subjects with active infection that requires systemic treatment
History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of child bearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
University of Utah
Lead sponsor
Lentigen Technology, Inc.
Collaborator
Huntsman Cancer Institute/ University of Utah
Collaborator