This phase I trial studies the side effects and best dose of CD19.CAR T cells in treating participants with CD19 positive malignancies after stem cell transplant. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T lymphocytes, such as CD19.CAR T cells, may kill tumor cells but there normally are not enough of them to kill all the tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02050347.
PRIMARY OBJECTIVES:
I. To evaluate the safety and persistence of escalating doses of CD19CAR-CD28zeta-4-1BB-expressing Allogeneic T Lymphocytes (allogeneic- CD3/CD28 activated peripheral blood T lymphocytes [ATL]) genetically modified to express artificial T-cell receptors (CAR) targeting the CD19 molecule (CD19.CAR), given for prophylaxis, persistence or relapse of high risk B-cell malignancies post hematopoietic stem cell transplant (HSCT). Cells will be infused in a lymphodepleted environment.
SECONDARY OBJECTIVES:
I. To evaluate the effects of gene modified ATL on measurable disease.
II. To evaluate the impact of the gene modified ATL on virus-specific T-lymphocyte immune reconstitution.
III. To evaluate the impact of the gene modified ATL on normal CD19+ B-cell immune reconstitution post-hematopoietic stem cell transplant (HSCT).
OUTLINE: This is a dose-escalation study.
Participants receive CD19.CAR T cells intravenously (IV) over 10 minutes during day 0. Participants experiencing benefit after 6 weeks may receive up to 5 additional doses of CD19.CAR T cells at least 4-6 apart.
After completion of study treatment, participants are followed up 3, 6, 9, and 12 months, every 6 months for 4 years, and then annually for up to 15 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorCarlos Almeida Ramos