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Holly Meany

TAA-Ts as therapy for tumors

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Holly Meany

“The T cell immunotherapy regimen resulted in prolonged disease stabilization in patients who previously experienced rapid tumor progression,” says Holly Meany, M.D. “The therapy could prove to be an important component of immunotherapy for patients with solid tumor malignancies.”

In a study published in the Journal of Clinical Oncology, researchers from Children’s National Health System uncovered tumor-associated antigen cytotoxic T Cells (TAA-Ts) that represent a new and potentially effective nontoxic therapeutic approach for patients with relapsed or refractory solid tumors.

The Phase 1 study led by Children’s National pediatric oncologists Holly Meany, M.D., and Amy B. Hont, M.D., represented the first in-human trial investigating the safety of administering TAA-Ts that target Wilms Tumor gene 1, a preferentially expressed antigen of melanoma and survivin in patients with relapsed/refractory solid tumors.

“These are exciting clinical results using a novel ‘first in-human’ T cell therapy,” said Catherine Bollard, MB.Ch.B., M.D., director of the Center for Cancer and Immunology Research at Children’s Research Institute. “This T cell therapy was safe and appeared to prolong patients’ time to progression which suggests that we can now use this novel treatment as a combination therapy to hopefully achieve long-term remissions in pediatrics and adults with relapsed/refractory solid tumors.”

During the Phase 1 trial, TAA-Ts products were generated from autologous peripheral blood and were infused over three dose levels. Patients were then eligible for up to eight infusions that were administered four to seven weeks apart.

Of the 15 evaluable patients, 11 were with stable disease or better at 45 days post-infusion and were defined as responders. Patients who were treated at the highest dose level showed the best clinical outcomes, with a 6-month progression-free survival rate of 73% after TAA-Ts infusion, an improvement as compared with prior therapy.

Overall, the Phase 1 trial of TAA-Ts resulted in safely induced disease stabilization and was associated with antigen spreading and a reduction in circulating tumor-associated antigen DNA levels in patients with relapsed/refractory solid tumors before infusion.

“The T cell immunotherapy regimen resulted in prolonged disease stabilization in patients who previously experienced rapid tumor progression,” said Dr. Meany. “The therapy could prove to be an important component of immunotherapy for patients with solid tumor malignancies,” she added.

The other researchers that contributed to this work are as follows: Amy B. Hont, M.D.; C. Russell Cruz, M.D., Ph.D.; Robert Ulrey, M.S.; Barbara O’Brien, B.S.; Maja Stanojevic, M.D.; Anushree Datar, M.S.; Shuroug Albihani, M.S.; Devin Saunders, B.A.; Ryo Hanajiri, M.D., Ph.D.; Karuna Panchapakesan, M.S.; Sam Darko, M.S.; Payal Banerjee, M.S.; Maria Fernanda Fortiz, B.S.; Fahmida Hoq, MBBS, M.S.; Haili Lang, M.D.; Yunfei Wang, Dr.PH.; Patrick J. Hanley, Ph.D.; Jeffrey S. Dome, M.D., Ph.D.; Catherine M. Bollard, M.D.; and Holly J. Meany, M.D.

QUILT conference

Children’s National hosts Quality Improvement Leadership Training Course

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QUILT conference

In October 2018, Children’s National hosted 20 neonatologists from 15 hospitals in China for a 10 day Quality Improvement Leadership Training Course focused on quality improvement principles and methodology. The course also featured presentations on hospital-wide quality improvement work and included speakers from the Quality & Safety Department, Nursing Quality, and the Neonatal Intensive Care Unit (NICU). The Performance Improvement team worked with the attendees on their own projects, such as reducing antibiotic use and increasing family-centered care in the NICU. The attendees then presented at the end of the course to their colleagues, as well as to five hospital presidents visiting from China.

Children’s National safety experts share strategies

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Rahul Shah

Rahul Shah, M.D., Vice President and Chief Quality and Safety Officer at Children’s National Health System (CNHS), and his team joined pediatric quality and safety leaders from across the country in Orlando, Fla. for the Children’s Hospital Association’s 2017 Quality & Safety in Children’s Health Conference.

Earlier this month, Rahul Shah, M.D., Vice President and Chief Quality and Safety Officer at Children’s National Health System (CNHS), and his team joined pediatric quality and safety leaders from across the country in Orlando, Fla. for the Children’s Hospital Association’s 2017 Quality & Safety in Children’s Health Conference. Dr. Shah shared findings and strategies that have led Children’s National to be a leader in this field, and collaborated with peers to move the needle on pediatric safety in hospitals and improving the quality of care hospitals deliver.

Notable presentations from the Children’s National team included:

  • The Children’s National utilization of a safety culture survey called the Safety Attitude Questionnaire (SAQ), and the crucial role of ensuring leadership alignment in the survey process. Obtaining leadership buy-in and alignment allowed Children’s to accelerate the spread of identified opportunities for improvement within the organization.
  • The importance of an ongoing multi-disciplinary approach to care for psychiatry patients, a patient population that that continues to increase in American pediatric healthcare and requires innovative approaches. Children’s National team members emphasized the importance of training the hospital’s security teams and front-line caregivers in therapeutic interventions to seek optimal outcomes for patients, while respecting the complexity of their diagnoses.
  • How to drive reliability through apparent cause analyses. Kristen Crandall, Director of Patient Safety at Children’s National, shared examples of how to leverage data to effectively drive change in cause analyses. Cause analyses are fundamental tools for implementing improvement. The team highlighted the upcoming launch of a High Reliability Toolkit© developed at CNHS to ensure that action plans created from cause analyses are of adequate depth and sophistication to drive improvements.

Dr. Shah and his team also had the honor of delivering an Impact session on the final day of the conference, in which they discussed the applications of merging patient safety with patient experience. The team also shared the Children’s National approach to safety and service, which includes delivering a unified framework of high reliability through consistent messaging to demonstrate that when safety and service integrate and align, the sum is greater than the parts.