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.
Resources from the same session
4761 - High-sensitivity troponin as a cardiotoxicity biomarker in breast cancer treatment
Presenter: Joana Simões
Session: Poster Display session 1
Resources:
Abstract
4852 - Impact of routine screening and preemptive treatment on hepatitis B virus reactivation (HBVr) in patients receiving chemotherapy
Presenter: Celine Marty
Session: Poster Display session 1
Resources:
Abstract
5225 - The uptake, patient satisfaction and efficacy of scalp cooling among patients receiving chemotherapy in an Irish oncology day ward.
Presenter: William Maher
Session: Poster Display session 1
Resources:
Abstract
1901 - Placebo adverse events (AEs) in targeted and immune cancer therapy in the adjuvant and advanced setting: A systematic review and meta-analysis
Presenter: Diego Enrico
Session: Poster Display session 1
Resources:
Abstract
3258 - Reduced antibody levels and high seronegativity rates against vaccine preventable diseases pose a risk factor for infections in patients with solid and hematologic cancers
Presenter: Angela Guzek
Session: Poster Display session 1
Resources:
Abstract
3211 - Prognostic Factors Influencing Outcome After Therapy With Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin's Lymphoma
Presenter: Veselina Goranova - Marinova
Session: Poster Display session 1
Resources:
Abstract
4949 - Phase I Study of CC-90010 in Patients With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma (R/R NHL)
Presenter: Victor Moreno
Session: Poster Display session 1
Resources:
Abstract
2271 - Pretreatment coagulation factors related to prognosis in patients with natural killer/T cell lymphoma
Presenter: Yue Chai
Session: Poster Display session 1
Resources:
Abstract
4335 - Diffuse large B cell lymphoma in the elderly. A retrospective analysis of standard versus alternative treatments
Presenter: Irene Sillero
Session: Poster Display session 1
Resources:
Abstract
5117 - MIPI as a superior prognostic tool in Mantle Cell Lymphoma compared to monocyte-lymphocyte, neutrophil-lymphocyte and platelet-lymphocyte ratios
Presenter: Filipa Macedo
Session: Poster Display session 1
Resources:
Abstract