Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 1

2961 - Safety and pharmacokinetics of novel CXCR4 antagonist YF-H-2015005 in the mobilization of hematopoietic stem cells in patients with non-Hodgkin's lymphoma

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Lymphomas

Presenters

Weiping Liu

Citation

Annals of Oncology (2019) 30 (suppl_5): v435-v448. 10.1093/annonc/mdz251

Authors

W. Liu1, Y. Xie1, L. Ping1, M. Jiang2, G. Zhang3, Y. Cui4, J. Xu4, M. Wu1, X. Leng1, X. Wang1, S. Wang5, G. Zhang5, J. Zhu1, Y. Song1

Author affiliations

  • 1 Department Of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital, 100142 - Beijing/CN
  • 2 National Drug Clinical Trial Center (gcp Center), Peking University Cancer Hospital-Beijing Cancer HospitalKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital, 100142 - Beijing/CN
  • 3 Department Of Pharmacy, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital, 100142 - Beijing/CN
  • 4 Department Of Pharmacy, Peking University First Hospital, 100034 - Beijing/CN
  • 5 Hefei Yifan Biopharmaceuticals Inc., Hefei Yifan Biopharmaceuticals Inc., 231200 - Hefei/CN

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2961

Background

YF-H-2015005, a new type of CXCR4 antagonist, has demonstrated an ability to mobilize CD34+ cells in peripheral blood in pre-clinical studies. In this study, we evaluated the safety and efficacy of YF-H-2015005, as well as its pharmacokinetic (PK) and pharmacodynamic (PD) characteristics when administered with granulocyte colony-stimulating factor (G-CSF) in patients with non-Hodgkin lymphoma (NHL).

Methods

This phase I, open-label, single arm study enrolled patients who had HNL, aged 18 to 65 years, and eligible for autologous stem cell transplantation. The stem cell mobilization regimen used was G-CSF (10 mg/kg/day subcutaneously) administration in the morning for up to 8 days, and YF-H-2015005 (0.24 mg/kg subcutaneously) initialed in the evening of the fourth day of G-CSF administration, and then continued for up to 4 days. Apheresis was initiated 9 to 10 hours after each evening dose of YF-H-2015005, and after the morning dose of G-CSF. Apheresis was repeated for up to 4 days or until ≥ 2 × 106 CD34+ cells/kg had been collected.

Results

A total of 15 patients (11 men and 4 women; median age 51 years, range 32-64 years) were enrolled in the study. Our PK data showed that YF-H-2015005 was rapidly absorbed after s.c. administration with a median Tmax of 0.5 hour, and then was rapidly cleared with a terminal half-life of 5.04 ± 1.00 hours. After the first dose of YF-H-2015005, a mean 2.0-fold to 2.9-fold increase in peripheral blood CD34+ cells from baseline was observed after 2 to 24 hours, with the maximum increase being observed at 10 hours after dosing. Fourteen (93%) patients reached the minimum target CD34+ cell collection of ≥ 2 × 106 cells/kg required for transplantation. No adverse event ≥ grade 3 or treatment-related serious adverse event occurred.

Conclusions

YF-H-2015005 was safe and effective when used to mobilize CD34+ cells for transplantation in patients with NHL.

Clinical trial identification

CTR20170925.

Editorial acknowledgement

Legal entity responsible for the study

Hefei Yifan Biopharmaceuticals Inc.

Funding

Hefei Yifan Biopharmaceuticals Inc.

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.