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Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors.

Publication ,  Journal Article
Herbert, GS; Vreeland, TJ; Clifton, GT; Greene, JM; Jackson, DO; Hardin, MO; Hale, DF; Berry, JS; Nichol, P; Yin, S; Yu, X; Wagner, TE; Peoples, GE
Published in: Vaccine
May 2018

Tumor vaccines use various strategies to generate immune responses, commonly targeting generic tumor-associated antigens. The tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is produced from DC loaded with autologous tumor antigens, creating a patient-specific vaccine. Here, we describe initial phase I/IIa trial results.This trial includes patients with any stage solid tumors, ECOG ≤1, and >4 months life-expectancy. A personalized vaccine is created using 1 mg of tumor and 120 ml blood (to isolate DC). Primary vaccination series (PVS) is four monthly inoculations. Patients are followed per standard of care (SOC). Endpoints include safety and tumor response (RECIST v1.1).44 patients were enrolled and vaccinated consisting of 31 late stage patients with residual/measurable disease, and 13 disease-free patients after SOC therapies. While 4 patients progressed before completing the PVS, 12/31 (39%) demonstrated clinical benefit (2 complete responses, 4 partial responses, 6 stable disease). In the adjuvant setting, 46% of late stage patients remain disease free at a median of 22.5 months.The TLPLDC vaccine is scalable, generates a personalized DC vaccine, and requires little autologous tumor tissue and few DC. The vaccine is safe, with primarily grade 0-2 toxicities, and nearly 40% clinical benefit rate in varied tumors, warranting further study.ISRCTN81339386, Registered 2/17/2016.

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Published In

Vaccine

DOI

EISSN

1873-2518

ISSN

0264-410X

Publication Date

May 2018

Volume

36

Issue

23

Start / End Page

3247 / 3253

Related Subject Headings

  • Virology
  • Treatment Outcome
  • Precision Medicine
  • Neoplasms
  • Middle Aged
  • Male
  • Immunotherapy
  • Humans
  • Female
  • Dendritic Cells
 

Citation

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Herbert, G. S., Vreeland, T. J., Clifton, G. T., Greene, J. M., Jackson, D. O., Hardin, M. O., … Peoples, G. E. (2018). Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors. Vaccine, 36(23), 3247–3253. https://doi.org/10.1016/j.vaccine.2018.04.078
Herbert, Garth S., Timothy J. Vreeland, Guy T. Clifton, Julia M. Greene, Doreen O. Jackson, Mark O. Hardin, Diane F. Hale, et al. “Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors.Vaccine 36, no. 23 (May 2018): 3247–53. https://doi.org/10.1016/j.vaccine.2018.04.078.
Herbert GS, Vreeland TJ, Clifton GT, Greene JM, Jackson DO, Hardin MO, et al. Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors. Vaccine. 2018 May;36(23):3247–53.
Herbert, Garth S., et al. “Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors.Vaccine, vol. 36, no. 23, May 2018, pp. 3247–53. Epmc, doi:10.1016/j.vaccine.2018.04.078.
Herbert GS, Vreeland TJ, Clifton GT, Greene JM, Jackson DO, Hardin MO, Hale DF, Berry JS, Nichol P, Yin S, Yu X, Wagner TE, Peoples GE. Initial phase I/IIa trial results of an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with solid tumors. Vaccine. 2018 May;36(23):3247–3253.
Journal cover image

Published In

Vaccine

DOI

EISSN

1873-2518

ISSN

0264-410X

Publication Date

May 2018

Volume

36

Issue

23

Start / End Page

3247 / 3253

Related Subject Headings

  • Virology
  • Treatment Outcome
  • Precision Medicine
  • Neoplasms
  • Middle Aged
  • Male
  • Immunotherapy
  • Humans
  • Female
  • Dendritic Cells