Clinical Cell and Vaccine Production Facility
The Clinical Cell and Vaccine Production Facility (CVPF) renders bench-to-bedside translational medicine a reality. Equipped with state of the art facilities, the CVPF manufactures cell and gene biotherapeutics and is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) as well as by the College of American Pathologists (CAP). Further, the CVPF is the only GMP (good manufacturing practices) compliant facility on campus and functions as an NCI approved Abramson Cancer Center (ACC) Shared Resource. As an ACC Shared Resource and Path and BioResources core facility, the CVPF supports numerous investigational new drug (IND) protocols. Current protocols target a variety of disease indications (primarily HIV, adult and pediatric cancers, and stroke); many more trials are in development and, once approved, will further expand the scope of diseases targeted for cell and gene therapy. For more information on current trials, explore our “Clinical Trials” page.
Current Clinical Trials
  • Cancer Trials
  • HIV Trials

CTL019 Therapy: Recent Publication

The CVPF is excited to announce its latest CTL019 research findings, published in The New England Journal of Medicine on 16 October 2014. For the full research article, please click here.

Chimeric Antigen Receptor T Cells
for Sustained Remissions in Leukemia

Shannon L. Maude, M.D., Ph.D., Noelle Frey, M.D., Pamela A. Shaw, Ph.D., Richard Aplenc, M.D., Ph.D., David M. Barrett, M.D., Ph.D., Nancy J. Bunin, M.D., Anne Chew, Ph.D., Vanessa E. Gonzalez, M.B.A., Zhaohui Zheng, M.S., Simon F. Lacey, Ph.D., Yolanda D. Mahnke, Ph.D., Jan J. Melenhorst, Ph.D., Susan R. Rheingold, M.D., Angela Shen, M.D., David T. Teachey, M.D., Bruce L. Levine, Ph.D., Carl H. June, M.D., David L. Porter, M.D., and Stephan A. Grupp, M.D., Ph.D.
N Engl J Med 2014; 371:1507-1517October 16, 2014DOI: 10.1056/NEJMoa1407222

Results (from The New England Journal of Medicine abstract)

A total of 30 children and adults received CTL019. Complete remission was achieved in 27 patients (90%), including 2 patients with blinatumomab-refractory disease and 15 who had undergone stem-cell transplantation. CTL019 cells proliferated in vivo and were detectable in the blood, bone marrow, and cerebrospinal fluid of patients who had a response. Sustained remission was achieved with a 6-month event-free survival rate of 67% (95% confidence interval [CI], 51 to 88) and an overall survival rate of 78% (95% CI, 65 to 95). At 6 months, the probability that a patient would have persistence of CTL019 was 68% (95% CI, 50 to 92) and the probability that a patient would have relapse-free B-cell aplasia was 73% (95% CI, 57 to 94). All the patients had the cytokine-release syndrome. Severe cytokine-release syndrome, which developed in 27% of the patients, was associated with a higher disease burden before infusion and was effectively treated with the anti–interleukin-6 receptor antibody tocilizumab.

Conclusions (from The New England Journal of Medicine abstract)

Chimeric antigen receptor–modified T-cell therapy against CD19 was effective in treating relapsed and refractory ALL. CTL019 was associated with a high remission rate, even among patients for whom stem-cell transplantation had failed, and durable remissions up to 24 months were observed. (Funded by Novartis and others; CART19 numbers, NCT01626495 and NCT01029366.)

A nanoflight View of Immune Cells Engineered to Fight Cancer
Sample Preparation by Ray Meade,
Electron Microscopy Resource Lab, Perelman School of Medicine
nanoflight video by © Scientific Photography – Stefan Diller, Germany

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