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Motixafortide

DRUG8 trials

Sponsors

Bioline Rx Ltd., Gulam Manji, Washington University School of Medicine, St. Jude Children's Research Hospital, Emory University

Conditions

Acute Myeloid LeukemiaAdenocarcinomaAdenocarcinoma of the PancreasHematopoietic Stem Cell mobilization autologous transplantation in Multiple MyelomaMeasurable Residual DiseaseMultiple MyelomaPancreatic CancerSickle Cell Disease

Phase 1

Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)
CompletedNCT05618301
Washington University School of MedicineSickle Cell Disease
Start: 2023-07-07End: 2025-06-24Updated: 2025-08-11
SCD Stem Cell Mobilization and Apheresis Using Motixafortide
RecruitingNCT06442761
St. Jude Children's Research HospitalSickle Cell Disease
Start: 2024-11-14End: 2028-07-01Target: 15Updated: 2026-01-30
Gene Editing For Sickle Cell Disease
RecruitingNCT06506461
St. Jude Children's Research HospitalSickle Cell Disease
Start: 2025-03-21End: 2032-12-31Target: 25Updated: 2025-11-14
A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization
CompletedNCT06547112
Washington University School of MedicineMultiple Myeloma
Start: 2024-10-31End: 2025-08-19Updated: 2025-08-29

Phase 2

Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
RecruitingNCT04543071
Gulam ManjiAdenocarcinoma, Adenocarcinoma of the Pancreas, Pancreatic Cancer
Start: 2020-11-09End: 2028-08-31Target: 10Updated: 2025-06-19
Motixafortide for MRD Sensitization in AML
Not yet recruitingNCT07392970
Washington University School of MedicineAcute Myeloid Leukemia, Measurable Residual Disease
Start: 2026-03-31End: 2029-10-02Target: 10Updated: 2026-02-06

Phase 3

A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects with Multiple Myeloma – The GENESIS Study
Active, not recruitingCTIS2024-511953-23-00
Bioline Rx Ltd.Hematopoietic Stem Cell mobilization autologous transplantation in Multiple Myeloma
Start: 2019-05-17Target: 44Updated: 2025-02-13

Phase 4

Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial
RecruitingNCT07101445
Emory UniversityMultiple Myeloma
Start: 2025-09-24End: 2027-12-31Target: 94Updated: 2026-02-10

Related Papers

Improved hematopoietic stem cell mobilization for gene therapy using single agent motixafortide in sickle cell disease
Blood2025-11-03
Motixafortide (CXCR4 inhibition) alone and in combination with natalizumab (VLA-4 inhibition) to mobilize hematopoietic stem cells for gene therapy in sickle cell disease: A first-in-human, safety and feasibility study
Blood2025-11-03
Motixafortide + G-CSF hematopoietic stem cell mobilization in patients with multiple myeloma following quadruplet induction therapy
Blood2025-11-03
CheMo4METPANC: Combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in metastatic treatment-naïve pancreatic adenocarcinoma—Updated clinical and translational findings.
Journal of Clinical Oncology2025-05-28
SAGES1: Clinical Translation of CRISPR Genome Editing Strategy to Induce Fetal Hemoglobin to Treat Sickle Cell Disease
Blood2024-11-053 citations
Motixafortide for Hematopoietic Stem and Progenitor Cell Mobilization and Collection in Sickle Cell Disease
Blood2024-11-053 citations
CheMo4METPANC: A randomized phase 2 study with combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) compared to chemotherapy alone in metastatic treatment-naïve pancreatic adenocarcinoma.
Journal of Clinical Oncology2024-06-01
Abstract PR05: CheMo4METPANC: Combination Chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in METastatic treatment-naïve PANCreatic adenocarcinoma
Cancer Research2024-01-16
CheMo4METPANC: A phase 2 study with combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) Motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in metastatic treatment-naïve pancreas adenocarcinoma.
Journal of Clinical Oncology2023-06-015 citations
Chemo4MetPanc: A phase II study with combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in metastatic treatment naïve pancreas adenocarcinoma (PDAC).
Journal of Clinical Oncology2021-01-205 citations