15 completed, 5 terminated, 2 unknown, 1 active not recruiting. 16 Phase 2, 12 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 10, Terminated 4, Unknown 2 |
| Phase 1 | 12 | Completed 7, Terminated 4, Unknown 1 |
| Phase 3 | 2 | Active not recruiting 1, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization Motixafortide, G-CSF - Multiple Myeloma | Phase 1 | Completed | Washington University School of Medicine | 20 | 2024-10-31 | 2025-08-29 |
| Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD) Motixafortide, Natalizumab, Leukapheresis - Sickle Cell Disease | Phase 1 | Completed | Washington University School of Medicine | 10 | 2023-07-07 | 2025-08-11 |
| Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects 1.25 mg/kg BL-8040 + BL-8040-matching placebo, 2 mg/kg BL-8040, BL-8040-matching placebo - Healthy Subjects | Phase 1 | Completed | BioLineRx, Ltd. | 38 | 2021-06-11 | 2025-03-21 |
| A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) BL-8040 1.25 mg/kg + G-CSF, Placebo +G-CSF - Multiple Myeloma | Phase 3 | Active not recruiting | BioLineRx, Ltd. | 180 | 2018-03-23 | 2026-01-15 |
| Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML) BL-8040, Atezolizumab - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Terminated | BioLineRx, Ltd. | 1 | 2018-01-08 | 2024-09-05 |
| A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin - Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma | Phase 1 / Phase 2 | Terminated | Hoffmann-La Roche | 219 | 2017-10-13 | 2026-08-03 |
| Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients BL-8040, Pembrolizumab, Chemotherapy - Metastatic Pancreatic Adenocarcinoma | Phase 2 | Completed | BioLineRx, Ltd. | 80 | 2016-09-01 | 2024-08-28 |
| Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies BL-8040, Leukapheresis, Hematopoietic cell transplant - Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia | Phase 2 | Completed | Washington University School of Medicine | 50 | 2016-03-31 | 2023-11-07 |
| Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome BL-8040, horse anti-thymocyte globulin (hATG), Methylprednisolone - Aplastic Anemia, Hypoplastic Myelodysplastic Syndrome | Phase 2 | Completed | BioLineRx, Ltd. | 11 | 2015-10-01 | 2020-12-29 |
| BL-8040 Addition to Consolidation Therapy in AML Patients Cytarabine, BL-8040, Placebo (for BL-8040) - Acute Myeloid Leukemia | Phase 2 | Unknown | Dr. Petra Tschanter | 194 | 2015-09-01 | 2015-09-21 |
| A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers BL-8040, Placebo - Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB) | Phase 1 | Completed | BioLineRx, Ltd. | 33 | 2014-08-01 | 2015-07-31 |
| Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients. BL-7010, Placebo - Celiac Disease | Phase 1 / Phase 2 | Completed | BioLineRx, Ltd. | 40 | 2013-12-01 | 2017-08-18 |
| Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C Ribavirin, Hydroxychloroquine - Hepatitis C | Phase 1 / Phase 2 | Terminated | BioLineRx, Ltd. | 4 | 2013-04-01 | 2014-08-28 |
| Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients Ara-C, BL-8040 - Acute Myeloid Leukemia | Phase 2 | Completed | BioLineRx, Ltd. | 42 | 2013-04-01 | 2024-09-19 |
| Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis BL-7040 - Ulcerative Colitis | Phase 2 | Completed | BioLineRx, Ltd. | 22 | 2012-03-01 | 2014-07-15 |
| A Study Intended to Evaluate Safety, Tolerability and Pharmacokinetics (PK) Parameters of BL-1021 BL-1021, 1021 - Healthy, Volunteers | Phase 1 | Terminated | BioLineRx, Ltd. | 32 | 2011-06-01 | 2014-03-13 |
| Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia CYP-1020, Risperidone - Schizophrenia, Cognitive Effect on Schizophrenic Patients | Phase 2 / Phase 3 | Terminated | BioLineRx, Ltd. | 269 | 2011-05-01 | 2014-09-18 |
| A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study BL - 1020, Placebo, Risperidone - Schizophrenia | Phase 2 | Completed | BioLineRx, Ltd. | 360 | 2008-07-01 | 2010-06-29 |
| Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 BL-1020, BL-1020 10-30 mg, risperidone - Schizophrenia | Phase 2 | Completed | BioLineRx, Ltd. | 220 | 2008-06-01 | 2010-06-29 |
| Safety and Feasibility of the Injectable BL-1040 Implant BL-1040 - Cardiovascular Disease | Phase 1 / Phase 2 | Unknown | BioLineRx, Ltd. | 30 | 2008-03-01 | 2012-02-03 |
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Leukemia, Myeloid, Acute (4) · Schizophrenia (4) · Multiple Myeloma (3) · Acute Pain (1) · Anemia, Aplastic (1) · Anemia, Sickle Cell (1) · Cardiovascular Diseases (1) · Celiac Disease (1) · Colitis, Ulcerative (1) · Esophageal Neoplasms (1) · Hepatitis C (1) · Hodgkin Disease (1) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (1) · Lymphoma, Non-Hodgkin (1) · Myelodysplastic Syndromes (1)
4-fluorobenzoyl-TN-14003 (12) · perphenazine GABA ester (5) · Risperidone (3) · Cytarabine (2) · Fluorouracil (2) · Granulocyte Colony-Stimulating Factor (2) · Leucovorin (2) · Leukapheresis (2) · atezolizumab (2) · Antilymphocyte Serum (1) · Cisplatin (1) · Cyclosporine (1) · Drug Therapy (1) · Hydroxychloroquine (1) · Linagliptin (1)
United States (12) · Israel (9) · Spain (4) · Germany (3) · Romania (2) · South Korea (2) · Australia (1) · Czechia (1) · Finland (1) · France (1) · Hungary (1) · India (1) · Italy (1) · Moldova (1) · Poland (1)
Arnon Aharon, MD (3) · Zachary Crees, M.D. (2) · Abi Vainstein, MD (1) · Alex Fisch, MD (1) · Crees Zachary, MD (1) · Eran Goldin, MD (1) · Eran Israeli, MD (1) · Geoffrey Uy, M.D. (1) · John DiPersio, MD (1) · Marc Bourliere, MD (1) · Mary Ann Knisevich, MD (1)
PMID 23059159, PMID 31495201, PMID 32451495, PMID 36940261, PMID 37069359, PMID 41449151, PMID 41980027
2016 (1)