BL-8040

DRUG11 trials

Sponsors

BioLineRx, Ltd., Sheba Medical Center, Dr. Petra Tschanter, Washington University School of Medicine, Hoffmann-La Roche

Conditions

Acute Lymphoblastic LeukemiaAcute Myelogenous LeukemiaAcute Myeloid LeukemiaAdult T Lymphoblastic LymphomaAplastic AnemiaChronic Myelogenous LeukemiaChronic Myeloid LeukemiaGastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma

Phase 1

A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers

CompletedNCT02073019

BioLineRx, Ltd.Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)

Start: 2014-08-31End: 2015-07-31Updated: 2015-07-31

Imatinib and BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia

WithdrawnNCT02115672

Sheba Medical CenterChronic Myeloid Leukemia

Start: 2014-11-30End: 2018-11-30Updated: 2016-08-15

Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)

TerminatedNCT03154827

BioLineRx, Ltd.Acute Myeloid Leukemia

Start: 2018-01-08End: 2020-04-01Updated: 2024-09-05

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

CompletedNCT03193190

Hoffmann-La RochePancreatic Adenocarcinoma

Start: 2017-07-05End: 2025-02-27Updated: 2025-11-21

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)

CompletedNCT03281369

Hoffmann-La RocheGastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma

Start: 2017-10-13End: 2025-10-09Updated: 2025-12-15

Phase 2

Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients

CompletedNCT01838395

BioLineRx, Ltd.Acute Myeloid Leukemia

Start: 2013-04-30End: 2023-07-20Updated: 2024-09-19

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

CompletedNCT02462252

BioLineRx, Ltd.Aplastic Anemia, Hypoplastic Myelodysplastic Syndrome

Start: 2015-10-31End: 2020-11-30Updated: 2020-12-29

BL-8040 Addition to Consolidation Therapy in AML Patients

Dr. Petra TschanterAcute Myeloid Leukemia

Start: 2015-09-30Target: 194Updated: 2015-09-21

Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

CompletedNCT02639559

Washington University School of MedicineAcute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia +8

Start: 2016-03-31End: 2023-04-07Updated: 2023-11-07

BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma

TerminatedNCT02763384

Washington University School of MedicineAdult T Lymphoblastic Lymphoma, T-Acute Lymphoblastic Leukemia

Start: 2016-12-02End: 2022-05-22Updated: 2023-10-31

Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients

CompletedNCT02826486

BioLineRx, Ltd.Metastatic Pancreatic Adenocarcinoma

Start: 2016-09-30End: 2022-09-06Updated: 2024-08-28

Related Papers

Abstract 2440: Single-cell MRD profiling identifies CXCR4-high AML as a responder population to CXCR4 inhibition with Motixafortide

Cancer Research2026-04-03

Atezolizumab and Motixafortide, Cobimetinib or Simlukafusp Alfa in Pretreated Advanced Pancreatic Cancer: Phase I/IIb MORPHEUS-PDAC Umbrella Study.

2026-02-25

First-line tiragolumab plus atezolizumab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic oesophageal cancer (MORPHEUS-EC): a randomised, open-label, phase 1b/2 trial.

2026-01-01

Blocking CXCR4<sup>+</sup> CD4<sup>+</sup> T cells reprograms T<sub>reg</sub>-mediated immunosuppression via modulating the Rho-GTPase/NF-κB signaling axis.

2025-08-041 citations

Clonal Dynamics of Leukemic and Clonal Hematopoiesis Mutations Predict Relapse in Single Cell MRD Analysis of AML in First Complete Remission

Blood2024-11-05

Abstract CT212: Phase Ib/II, global, open-label, randomized evaluation of atezolizumab (atezo) + etrumadenant (etruma) + chemotherapy (chemo) vs chemo alone in MORPHEUS-PDAC

Cancer Research2024-04-05

MORPHEUS-EC: A phase Ib/II open-label, randomized study of first-line tiragolumab (tira) + atezolizumab (atezo) + chemotherapy (CT) in patients (pts) with esophageal cancer (EC).

Journal of Clinical Oncology2024-01-206 citations

Phase 2 study of preoperative chemotherapy with nab‐paclitaxel and gemcitabine followed by chemoradiation for borderline resectable or node‐positive pancreatic ductal adenocarcinoma

Cancer Medicine2023-05-034 citations

Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial

Nature Medicine2023-04-0167 citations

Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform

The Oncologist2023-03-2048 citations

Signaling pathways in cancer-associated fibroblasts: recent advances and future perspectives.

2022-11-24186 citations

Motixafortide and Pembrolizumab Combined to Nanoliposomal Irinotecan, Fluorouracil, and Folinic Acid in Metastatic Pancreatic Cancer: The COMBAT/KEYNOTE-202 Trial

Clinical Cancer Research2021-07-1276 citations

Combined Inhibition of CXCR4 Signaling and System xc- Transporter Activity Induces Synthetic Lethality in T-ALL Cells By Suppressing Gsh and Inducing Ferroptosis

Blood2020-11-053 citations

259 Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC

Regular and Young Investigator Award Abstracts2020-11-012 citations

Abstract CT201: Phase Ib/II open-label, randomized evaluation of atezolizumab + cobimetinib vs control in MORPHEUS-NSCLC (non-small cell lung cancer), MORPHEUS-PDAC (pancreatic ductal adenocarcinoma) and MORPHEUS-GC (gastric cancer)

Cancer Research2020-08-154 citations

BL-8040, a CXCR4 antagonist, in combination with pembrolizumab and chemotherapy for pancreatic cancer: the COMBAT trial.

2020-05-25413 citations

Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC).

Journal of Clinical Oncology2020-05-208 citations

Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + BL-8040 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC).

Journal of Clinical Oncology2020-02-017 citations

MORPHEUS: A phase Ib/II study platform evaluating the safety and clinical efficacy of cancer immunotherapy (CIT)–based combinations in gastrointestinal (GI) cancers.

Journal of Clinical Oncology2019-01-2914 citations

The CXCR4 Antagonist, BL8040, Is Highly Active Against Human T-ALL in Preclinical Models

Blood2018-11-293 citations

12 more papers not shown