Adaptimmune announced that it has opened a Phase I/II, dual site, two-cohort, open-label clinical trial in multiple myeloma at the University of Maryland and the University of Pennsylvania testing its enhanced T cell receptor T cell therapy.
Adaptimmune is focused on the use of T cell therapy to treat cancer, with the body’s own machinery
the T lymphocyte cell – being used to target and destroy cancerous cells. This trial is designed to
investigate the safety, bioactivity and anti-tumor effect of infusion of patients’ own T cells that have
been genetically modified to express a high affinity T cell receptor (TCR) specific for a type of tumor
antigen (protein) known as a cancer testis antigen (CT antigen).
During the trial, TCRs that have been developed using Adaptimmune’s unique TCR enhancement
technology will be deployed to target two CT antigens called Mage-A3/6 and NYESO1. T cell
manufacturing will be performed at the Clinical Cell and Vaccine Production Facility at the Perelman
School of Medicine at the University of Pennsylvania.
Dr. Carl H. June at the Abramson Cancer Center of the University of Pennsylvania and Dr. Aaron
Rapoport of the University of Maryland Greenebaum Cancer Center developed the study design, which
was presented to the National Institutes of Health Recombinant DNA Advisory Committee last year. Dr.
June is the regulatory sponsor (FDA representative) for the study, and Dr. Edward Stadtmauer is the lead
clinical investigator at the Abramson Cancer Center. Dr. Rapoport is the lead clinical investigator at the
University of Maryland. Adaptimmune Ltd is the financial sponsor and owns the core T cell receptor
Multiple myeloma is a hematologic cancer localized to the bone marrow. With standard therapy, longterm response rates are low, and the median survival for patients with this disease is 3-5 years. The
clinical trial focuses on this unmet medical need and will include patients who have received prior
treatment for their myeloma and who are eligible for an autologous stem cell transplant (ASCT). ASCT is
the transplant of a patient’s own stem cells, which is a standard of care for treatment of multiple
myeloma in the U.S. Infusion of the CT antigen-specific T cells will occur just following ASCT. Drs.
Rapoport, Stadtmauer and June have collaborated and extensively published on three prior clinical trials
evaluating T cell infusion post ASCT, and have demonstrated that the procedure is safe and promotes
reconstitution of the immune system. The aim of the current trial is to improve the anti-tumor efficacy
of the T cell infusion by genetically redirecting the T cells to specifically recognize the patients’ tumor.