Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate the CXCR4 antagonist motixafortide across hematologic malignancies and solid tumors, including acute myeloid leukemia, multiple myeloma, sickle cell disease, and pancreatic adenocarcinoma. Sponsored by biopharmaceutical entities and academic centers, these protocols feature varied study designs with recruitment statuses including recruiting, active not recruiting, completed, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06506461 RECRUITING
Sickle Cell Disease
St. Jude Children's Research Hospital
 2025-03-21 PHASE1
NCT07392970 RECRUITING
Acute Myeloid Leukemia; Measurable Residual Disease
Washington University School of Medicine
 2026-07-23 PHASE2
NCT04543071 RECRUITING
Pancreatic Cancer; Adenocarcinoma of the Pancreas; Adenocarcinoma
Gulam Manji
 2020-11-09 PHASE2
NCT06442761 RECRUITING
Sickle Cell Disease
St. Jude Children's Research Hospital
 2024-11-14 PHASE1
NCT06514508 RECRUITING
Multiple Myeloma
Guangzhou Gloria Biosciences Co., Ltd.
 2025-12-01 PHASE3
NCT07101445 RECRUITING
Multiple Myeloma
Emory University
 2025-09-24 PHASE4
NCT03281369 TERMINATED
Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Hoffmann-La Roche
 2017-10-13 PHASE1; PHASE2
NCT06547112 COMPLETED
Multiple Myeloma
Washington University School of Medicine
 2024-10-31 PHASE1
NCT05618301 COMPLETED
Sickle Cell Disease
Washington University School of Medicine
 2023-07-07 PHASE1
NCT03193190 COMPLETED
Pancreatic Adenocarcinoma
Hoffmann-La Roche
 2017-07-05 PHASE1; PHASE2
NCT02907099 COMPLETED
Metastatic Pancreatic Adenocarcinoma; Recurrent Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v6 and v7
M.D. Anderson Cancer Center
 2016-12-01 PHASE2
NCT02826486 COMPLETED
Metastatic Pancreatic Adenocarcinoma
BioLineRx, Ltd.
 2016-09 PHASE2
NCT05293171 COMPLETED
Healthy Subjects
BioLineRx, Ltd.
 2021-06-11 PHASE1
NCT02763384 TERMINATED
T-Acute Lymphoblastic Leukemia; Adult T Lymphoblastic Lymphoma
Washington University School of Medicine
 2016-12-02 PHASE2
NCT03246529 ACTIVE_NOT_RECRUITING
Multiple Myeloma
BioLineRx, Ltd.
 2018-03-23 PHASE3
NCT02462252 COMPLETED
Aplastic Anemia; Hypoplastic Myelodysplastic Syndrome
BioLineRx, Ltd.
 2015-10 PHASE2
NCT03154827 TERMINATED
Acute Myeloid Leukemia
BioLineRx, Ltd.
 2018-01-08 PHASE1; PHASE2
NCT02502968 UNKNOWN
Acute Myeloid Leukemia
Dr. Petra Tschanter
 2015-09 PHASE2
NCT02639559 COMPLETED
Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Non-Hodgkin's Lymphoma; Non-Hodgkin Lymphoma; Hodgkin Disease; Hodgkins Disease; Hodgkin's Disease; Multiple Myeloma; Myelodysplastic Syndrome; Myeloproliferative Neoplasm
Washington University School of Medicine
 2016-03-31 PHASE2
NCT02115672 WITHDRAWN
Chronic Myeloid Leukemia
Sheba Medical Center
 2014-11 PHASE1; PHASE2
NCT01838395 COMPLETED
Acute Myeloid Leukemia
BioLineRx, Ltd.
 2013-04 PHASE2
NCT02073019 COMPLETED
Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
BioLineRx, Ltd.
 2014-08 PHASE1
NCT02115672 Withdrawn
Chronic Myeloid Leukemia
Sheba Medical Center
 2014-11 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-05-05)

Check the Motixafortide (BL-8040, BKT140) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Motixafortide functions as a potent antagonist of the chemokine receptor CXCR4, binding the receptor to alter miR-15a/16-1 expression and down-regulate downstream survival factors including ERK, BCL-2, MCL-1, and cyclin-D1. This pathway blockade induces apoptosis in malignant cells, providing the mechanistic foundation for its clinical evaluation in conditions such as acute myeloid leukemia, multiple myeloma, and pancreatic adenocarcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.