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Mavorixafor

DRUG8 trials

Sponsors

X4 Pharmaceuticals Inc., X4 Pharmaceuticals

Conditions

Healthy ParticipantsHepatic InsufficiencyNeutropeniaNeutropeniasWHIM SyndromeWaldenstrom's Macroglobulinemia

Phase 1

A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders
CompletedNCT04154488
X4 PharmaceuticalsNeutropenia
Start: 2021-10-16End: 2024-08-27Updated: 2025-08-06
A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4
CompletedNCT04274738
X4 PharmaceuticalsWaldenstrom's Macroglobulinemia
Start: 2020-04-30End: 2022-10-31Updated: 2024-08-27
A Study to Investigate Pharmacokinetics (PK) and Safety of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function
CompletedNCT06858696
X4 PharmaceuticalsHepatic Insufficiency
Start: 2025-02-28End: 2026-01-12Updated: 2026-07-15
Drug-Drug Interaction Potential of Mavorixafor
CompletedNCT06914869
X4 PharmaceuticalsHealthy Participants
Start: 2025-02-18End: 2025-05-19Updated: 2025-07-01

Phase 3

Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome
CompletedNCT03995108
X4 PharmaceuticalsWHIM Syndrome
Start: 2019-10-24End: 2025-12-23Updated: 2026-07-06
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections
RecruitingNCT06056297
X4 PharmaceuticalsNeutropenia
Start: 2024-06-06End: 2027-11-01Target: 176Updated: 2026-08-06
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of mavorixafor in participants with congenital and acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections.
RecruitingCTIS2023-508482-32-00
X4 Pharmaceuticals Inc.Neutropenias
Start: 2024-07-22Target: 86Updated: 2025-10-22
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Mavorixafor in Patients with WHIM Syndrome with Open-Label Extension
CompletedCTIS2024-518461-10-00
X4 Pharmaceuticals Inc.WHIM Syndrome
Start: 2026-01-12End: 2026-01-12Target: 6Updated: 2024-12-09

Related Papers

Trial in progress: A pivotal Phase 3 study to investigate efficacy, safety, and tolerability of mavorixafor in participants with primary chronic neutropenia – trial update
Blood2025-11-03
Role of genetic testing in diagnosing patients with severe congenital neutropenia: Results from PATH4WARD genetic testing program
Blood2025-11-03
Clinical Response Among Participants with Warts in the Phase 3 Trial, Mavorixafor, an Oral CXCR4 Antagonist, for Treatment of Patients with WHIM Syndrome
Journal of Human Immunity2025-04-251 citations
Mavorixafor Inhibits Pathogenic Cxcr4 Signaling and Function in T Lymphocytes from Patients with WHIM Syndrome in vitro
Journal of Human Immunity2025-04-251 citations
Six-year follow-up of phase II study exploring chemo-free treatment association with idelalisib and obinutuzumab in symptomatic relapsed/ refractory patients with Waldenström’s macroglobulinemia
Annals of Hematology2024-11-052 citations
Trials in Progress: A Phase 3 Study to Investigate Efficacy, Safety, and Tolerability of Mavorixafor in Participants with Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders
Blood2024-11-05
A phase 3 randomized trial of mavorixafor, a CXCR4 antagonist, for WHIM syndrome
Blood2024-04-2135 citations
Mavorixafor for Patients with Chronic Neutropenic Disorders Treated with G-CSF: Preliminary Response Data and G-CSF Dose Reduction in an Ongoing Phase 2, Open-Label, Multicenter Study Support Reduction in G-CSF Dosing
Blood2023-11-023 citations
S180: RESULTS OF A PHASE 3 TRIAL OF AN ORAL CXCR4 ANTAGONIST, MAVORIXAFOR, FOR TREATMENT OF PATIENTS WITH WHIM SYNDROME
HemaSphere2023-08-01
Mavorixafor for Patients with Chronic Neutropenic Disorders: Results from a Phase 1b, Open-Label, Multicenter Study
Blood2022-11-152 citations
Abstract 6093: Mavorixafor enhances efficacy of Bruton tyrosine kinase inhibitors by overcoming the protective effect of bone marrow stroma on tumor cells in Waldenström’s macroglobulinemia
Cancer Research2022-06-15
PB1938: 4WHIM: EVALUATING MAVORIXAFOR, AN ORAL CXCR4 ANTAGONIST, IN PATIENTS WITH WHIM SYNDROME VIA A GLOBAL PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED TRIAL WITH OPEN-LABEL EXTENSION
HemaSphere2022-06-012 citations
P1253: MAVORIXAFOR DISRUPTS THE CROSS TALK BETWEEN WALDENSTRÖM’S MACROGLOBULINEMIA CELLS AND THE BONE MARROW MICROENVIRONMENT RESULTING IN ENHANCED SENSITIVITY TO B-CELL TARGETED THERAPIES
HemaSphere2022-06-01
Preliminary Clinical Response Data from a Phase 1b Study of Mavorixafor in Combination with Ibrutinib in Patients with Waldenström's Macroglobulinemia with <i>MYD88</i> and <i>CXCR4</i> Mutations
Blood2021-11-0511 citations
Global Phase 3, Randomized, Placebo-Controlled Trial with Open-Label Extension Evaluating the Oral CXCR4 Antagonist Mavorixafor in Patients with WHIM Syndrome (4WHIM): Trial Design and Enrollment
Blood2021-11-053 citations
Long-term follow-up of ibrutinib monotherapy in treatment-naive patients with Waldenstrom macroglobulinemia
Leukemia2021-09-1678 citations
PRELIMINARY CLINICAL DATA FROM A PHASE 1B STUDY OF MAVORIXAFOR AND IBRUTINIB IN PATIENTS WITH WALDENSTRöM MACROGLOBULINEMIA WITH <i>MYD88</i> AND <i>CXCR4</i> MUTATIONS
Hematological Oncology2021-06-012 citations