Clinical trial · Interventional
Safety Study of a Chemokine Receptor (CXCR4) Antagonist in Multiple Myeloma Patients
A Phase I/IIA, Non-Randomized, Open Label, Single Dose, Dose-Escalation, Safety Study of BKT140, a CXCR4 Antagonist in Patients With Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
BKT-140 drug substance is a highly selective chemokine receptor (CXCR4) antagonist, which is developed by Biokine as a novel therapy for Multiple Myeloma (MM, a type of blood cancer). The unique combination of activities of BKT140, i.e., the induction of the exit of blood cells such as stem cells and mature cells from the bone marrow to the peripheral blood, coupled with specific induction of MM cell death by BKT-140, represents a novel therapeutic strategy against MM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BKT140 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- White blood cell (WBC) count
- timeFrame
- 24 hour
Secondary outcomes (1)
- measure
- CD34+ cells
- timeFrame
- 24 hour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females 18 to 65 years old inclusive * MM patients with clinically significant disease that achieved at least Partial Response (PR) after induction chemotherapy * Patients eligible for HDC with PBSC support. * Patients who require stem cell collection with CTX and G-CSF priming. * Normal LV functions (EF over 50%, DLCO over 50%) * Karnofsky score \> 60%, * Patients must have normal renal and liver functions as defined below: * Total bilirubin ≤2.0 x institutional upper limit of normal (ULN), unless the patient has a known diagnosis of Gilbert's disease. * Aspartate transaminase (AST, SGOT) or alanine transaminase (ALT, SGPT) ≤3 x institutional ULN. * Serum creatinine ≤1.5 g/dL or calculated estimated creatinine clearance ≥40 mL/min * Polymorphonuclear neutrophil (PMN) count \> 1,500 * PLT \>100,000 * Hemoglobin \> 9gr% * Women of child-bearing potential must have a negative serum or urine pregnancy test at enrollment. * If female, the patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide or abstinence) from the enrollment visit through 30 days after the administration of the study drug. * If male, the patient agrees to use an acceptable barrier method of contraception from the time of enrollment through 30 days after the administration of the study drug. * Prior to enrollment, the patient is capable of understanding the protocol and able to sign a written informed consent. Exclusion Criteria: * Patients who have not achieved at least Partial Response (PR) following induction chemotherapy. * No pervious G-CSF therapy. * Creatinine clearance \<40 mL /min. * Body temperature above 385 C on day 10. * Patients with blood pressure \<105/60 * Any of the following in the last 3 months prior to enrollment: Unstable Angina, Acute Myocardial Infarction (MI), Congestive Heart Failure, CVA, uncontrolled blood pressure * Pregnant or breast-feeding women. * Any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities. * Treatment with any investigational agents in the last 21 days before study entry. * Any condition or circumstance which, in the opinion of the Investigator, would significantly interfere with the patient's protocol compliance and put the patient at increased risk.
References
Publications (1)
- BACKGROUNDAbraham M, Biyder K, Begin M, Wald H, Weiss ID, Galun E, Nagler A, Peled A. Enhanced unique pattern of hematopoietic cell mobilization induced by the CXCR4 antagonist 4F-benzoyl-TN14003. Stem Cells. 2007 Sep;25(9):2158-66. doi: 10.1634/stemcells.2007-0161. Epub 2007 May 24. PMID 17525235