Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Study of Cellular Immunotherapy With Donor Central Memory-derived Virus-specific CD8+ T-cells Engineered to Target CD19 for CD19+ Malignancies After Allogeneic Hematopoietic Stem Cell Transplant
This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy.
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of pre-emptive adoptive T cell therapy using ex vivo
expanded cytomegalovirus (CMV)- or Epstein-Barr virus (EBV)-specific T cells derived from
donor CD62L+ central memory (TCM) cells and genetically modified to express a CD19-specific
chimeric antigen receptor (CAR) in patients in complete remission after human leukocyte
antigen (HLA)-matched related donor hematopoietic stem cell transplantation (HCT) for CD19+
B cell malignancies at high risk of post-HCT relapse. (Cohort A)
II. To assess the safety and feasibility of adoptive T cell therapy using ex vivo expanded
CMV- or EBV-specific T cells derived from donor CD62L+ TCM cells and genetically modified to
express a CD19-specific CAR in patients with persistent, progressive or relapsed disease
after HLA-matched related donor HCT for CD19+ B cell malignancies. (Cohort B)
SECONDARY OBJECTIVES:
I. To determine the duration of in vivo persistence of adoptively transferred bi-specific
CD8+ T cells, and the phenotype of persisting T cells.
II. To determine if adoptively transferred bi-specific CD8+ T cells traffic to the bone
marrow and function in vivo.
III. To determine if adoptively transferred bi-specific CD8+ T cells proliferate in
allogeneic HCT recipients that reactivate CMV or EBV.
IV. To determine if the adoptive transfer of bi-specific CD8+ T cells eliminates CD19+ tumor
cells in the subset of patients with a measurable tumor burden prior to T cell transfer.
OUTLINE:
At least 30 days after HCT, patients will receive one intravenous (IV) infusion of CMV/CD19
or EBV/CD19 bi-specific CD8+ T cells.
After completion of study treatment, patients are followed up periodically for 15 years.
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