T-cell therapy clinical trial now offered to cancer patients at C.S. Mott Children’s Hospital

Michigan University. US: Innovative treatment uses patient’s own immune cells against acute lymphoblastic leukemia. A clinical trial using T-cell therapy that uses the patients’ own immune cells to hunt down cancer cells is now being offered at the University of Michigan’s C.S. Mott Children’s Hospital.

“For patients for whom we’ve exhausted all other options, this therapy has provided hope against a highly aggressive form of ALL, in situations where nothing else has been successful,” says John Levine, M.D., clinical director of the Pediatric Blood and Marrow Transplantation Program at C.S. Mott Children’s Hospital.

To begin the treatment process, researchers first extract a patient’s own T cells. They then use bioengineering techniques to reprogram each patient’s T cells into chimeric antigen receptor cells — the CTL019 cells — custom-designed to bind to a protein called CD19 that exists only on the surface of B cells. After being returned to the patient’s body, the CTL019 cells proliferate and then hunt B cells that express CD19. They also may persist in the circulation, which may guard against the cancer’s recurrence.

“We are very proud to play an active role in this exciting new research that can offer new breakthroughs and hope for our pediatric cancer patients,” says Levine, a professor of pediatrics in the University of Michigan Medical School.

In July 2014, the U.S. Food and Drug Administration designated CTL019 as a Breakthrough Therapy, helping to expedite its progress into broader clinical trials. The trial opened in late October at Mott. Patients interested in participating should contact the center at 1-800-865-1125 to determine eligibility.
Side effects from the treatment can include symptoms of cytokine release syndrome (CRS), which occurs when CAR cells and multiply in the patient’s body resulting in the release of cytokines.
CRS symptoms include varying degrees of flu-like symptoms with high fevers, nausea, muscle pain, and in some cases, low blood pressure and breathing difficulties. To find out more, go to:
https://umclinicalstudies.org/HUM00086954?topics=14304
https://clinicaltrials.gov/ct2/show/study/NCT02228096?term=ctl019&rank=1#contacts

“For patients for whom we’ve exhausted all other options, this therapy has provided hope against a highly aggressive form of ALL,"

--John Levine, M.D.

The University of Michigan is among several centers participating in a multi-site trial to test CTL019, which was developed by a research team at the University of Pennsylvania. Initial clinical trials of CTL019 have taken place at both Penn and The Children’s Hospital of Philadelphia. Penn and Novartis have an exclusive global collaboration to research, develop and commercialize targeted CAR immunotherapies for the treatment of cancers and are the sponsors of this clinical trial.
Disclosure: Dr. Levine is a paid consultant for Novartis, a company supporting the development of CTL019
About C.S. Mott Children’s Hospital: Since 1903, the University of Michigan has led the way in providing comprehensive, specialized health care for children. From leading-edge heart surgery that's performed in the womb to complete emergency care that's there when you need it, families from all over come to the University of Michigan C.S. Mott Children's Hospital for our pediatric expertise. Our new $754-million hospital provides private rooms, family-centered care from caregivers who are transforming and driving the future of medicine. Learn more at www.mottchildren.org