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
4228 - Clinical Evaluation of Drug-Eluting Bead Transcatheter Arterial Chemoembolization(D-TACE) versus Conventional TACE in Treatment of unresectable Hepatocellular Carcinoma
Presenter: Yi Chen
Session: Poster Display session 1
Resources:
Abstract
3930 - Safety profile of tepotinib in patients with advanced solid tumors: pooled analysis of phase I and II data
Presenter: Thomas Decaens
Session: Poster Display session 1
Resources:
Abstract
5373 - Drug-drug interaction profile of tepotinib with CYP3A and P-gp substrates
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
5455 - Bioavailability of tepotinib: impact of omeprazole and food
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
2618 - Tislelizumab Exposure-Response Analyses of Efficacy and Safety in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2563 - Population Pharmacokinetics of Tislelizumab in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2021 - The Addition of Metformin to Systemic Anticancer Therapy
Presenter: Jung Han Kim
Session: Poster Display session 1
Resources:
Abstract
5243 - Growth modulation index (GMI) as a comparative measure of clinical activity of larotrectinib versus prior systemic treatments in adult and pediatric TRK fusion cancer patients
Presenter: Antoine Italiano
Session: Poster Display session 1
Resources:
Abstract
598 - Analysis of the overall survival and main surrogates used for FDA approvals in solid and hematological malignancies.
Presenter: Maria Kleniewska-Wieczor
Session: Poster Display session 1
Resources:
Abstract
5381 - Comparison of intratumoral docetaxel exposure in cancer patients between nanoparticle entrapped docetaxel (CPC634) and conventional docetaxel (Cd): the CriTax study
Presenter: Ruben Van Eerden
Session: Poster Display session 1
Resources:
Abstract