Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Pilot Study of Autologous T Lymphocytes With Antibody-Dependent Cell Cytotoxicity in Patients With CD20-Positive B-Cell Malignancies
Despite advancement in chemotherapy, radiotherapy and haematopoietic stem cell transplant
(HSCT), and the recent introduction of more targeted therapies, a substantial proportion of
patients with B-cell malignancies, such as B-cell chronic lymphocytic leukemia (CLL) and
B-cell non-Hodgkin's lymphoma (NHL) still succumb to their malignancies. For CLL and
low-grade NHL, cure is achievable only with HSCT but such aggressive approach is not
justified as the initial therapy for most patients who have indolent disease; when disease
has progressed, transplant is either not feasible or ineffective. For high-grade B-cell NHL,
the availability of Rituximab has improved disease outcome but treatment failure portends
nearly inevitable death from disease or treatment-related complications. Thus, newer, more
effective therapies for patients with B-cell malignancies are urgently needed.
The present study translates recent laboratory findings into clinical application. In
patients with B-cell malignancies receiving the anti-CD20 antibody Rituximab as standard
therapy, the study aims to assess the feasibility and safety, as well as explore the
efficacy, of infusing autologous T-lymphocytes engineered to express a CD16-41BB-CD3zeta
chimeric receptor which mediates antibody-dependent cell cytotoxicity. Receptor expression
is achieved by electroporation of mRNA.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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