Immunotherapy is focused on harnessing and manipulating the natural ability of the immune system to fight cancers; it includes cell therapies, such as CAR-T, virotherapy and small molecules, such as monoclonal antibodies.
At Nationwide Children’s our comprehensive immunotherapy team includes oncologists, hematologists and experts in blood and marrow transplant and apheresis.
With cellular therapies, the whole is greater than the sum of its parts. Engineered cells are responsive and prolific and, hopefully, will yield therapies that are less toxic than the current therapies.
What is Kymriah™?
Kymriah™ (tisagenlecleucel, Novartis) is chimeric antigen receptor T cell (CAR-T) therapy that targets CD-19 B cells. In August 2017, it became the first CAR-T therapy approved by the FDA. Kymriah is a one-time treatment that has shown an 83 percent remission rate in clinical trials of patients with B cell acute lymphoblastic leukemia (B-ALL) who had not responded to traditional treatments.
For more information, call our BMT coordinators at (614) 355-1272.
Clinical Trials and Research
Nationwide Children’s is committed to the advancement of care through clinical research. With the first grant awarded from the Department of Defense (DOD) for investigating the application of cellular therapies in patients with neuroblastoma, the first open protocol for cellular therapy and the first patient at Nationwide Children’s infused this year, the Cellular Therapies team has paved the way for more firsts to come.
The team is on track to open ten cell therapy trials in 2018. The first study will be conducted through the New Advances Against Neuroblastoma (NANT) Consortium and will focus on the use of natural killer (NK) cells in neuroblastoma. Clinical trials in cellular therapy will include investigations of the following:
- Virus specific cytotoxic T lymphocytes (CTL) for Epstein bar virus
- Natural killer (NK) cells and small molecules for neuroblastoma (NANT)
- Virus specific CTL for cytomegalovirus
- CD19 chimeric antigen receptor (CAR) T cells for ALL and non-Hodgkin lymphoma patients who don’t qualify for Kymriah
- Chemotherapy with NK cells for AML re-induction
- Autologous NK cells for pediatric brain tumors
- Pediatric haplotransplant and NK cells for AML/MDS
Our research efforts are supported by the current Good Manufacturing Processes (cGMP) Clinical Manufacturing Facility (CMF) that operates according to FDA cGMP Guidelines to ensure the safety of manufactured biologic products.
Specialized Programs Improve Patient Care and Safety
The Host Defense Program, jointly created by the Divisions of Hematology, Oncology, & BMT and Infectious Diseases at Nationwide Children’s, is one of the country’s first pediatric-focused programs specifically designed to address infection prevention and management needs of immunocompromised children. It is also a translational research collaborative in which researchers work to improve the understanding of how pathogens and the immune system interact, ultimately working to develop novel therapeutic strategies.
Clinically, the team’s collaborative approach supports each child’s needs through an interdisciplinary team of experts in immunocompromised conditions. The Host Defense Program participates in multi-institutional clinical therapeutic trials that enable patients to have access to cutting-edge therapies directed against drug-resistant bacteria, invasive fungi, and viruses.
At Nationwide Children’s, our goal is zero – zero preventable harm for our patients, families and employees. This commitment to safety makes us a leader in the field, and the Zero Hero program has become exemplary of what is possible when professionals across the spectrum of health care work together. Through Zero Hero, Nationwide Children’s continues to reduce rates of hospital-acquired infections, medication errors and other complications that may exist in the health care setting. Zero Hero applies to all areas of the hospital, so whether a patient is receiving chemotherapy, attending a follow up visit, or admitted to the critical care unit, Our entire team is dedicated to keeping them safe and getting them well.
For information about the details of our cellular therapy clinical trials, including the status, eligibility criteria and collaboration opportunities, please contact one of our coordinators.
- Kristen McCrea, RN, BSN (614) 7224876
- Sharon Robison, RN, BSN (614) 7223806
- Cathy Gibson, RN, BSN (614) 355-1272