Numerous clinical trials evaluate Bisantrene (CS1) across diverse indications, including hematological malignancies such as acute myeloid leukemia, multiple myeloma, and myelodysplastic syndrome, as well as neuroinflammatory disorders like Alzheimer's and Parkinson's disease. Spanning Early Phase 1 through Phase 2, these academic- and industry-sponsored studies encompass active, completed, terminated, withdrawn, and enrolling-by-invitation recruitment statuses. Overall, this clinical landscape reflects targeted biomedical interest in Bisantrene for both oncological and neuroinflammatory conditions.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06185751 | RECRUITING | Multiple Myeloma |
Washington University School of Medicine |
2024-08-22 | PHASE1 |
| NCT07761572 | NOT_YET_RECRUITING | Pulmonary Arterial Hypertension |
Cereno Scientific AB |
2026-09-15 | PHASE2 |
| NCT05950113 | WITHDRAWN | Recurrent Multiple Myeloma; Refractory Multiple Myeloma |
Jonsson Comprehensive Cancer Center |
2024-03-28 | PHASE1 |
| NCT03710421 | SUSPENDED | Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma |
City of Hope Medical Center |
2019-04-23 | PHASE1 |
| NCT06574958 | UNKNOWN | ORR,OS,PFS |
The Second Hospital of Shandong University |
2024-04-30 | EARLY_PHASE1 |
| NCT04989335 | UNKNOWN | Myelogenous Leukemia, Acute |
Sheba Medical Center |
2021-08-02 | PHASE2 |
| NCT04886934 | UNKNOWN | Cardiac Disease; Myocardial Dysfunction |
Cardiaccs AS |
2021-10-25 | |
| NCT05224531 | COMPLETED | Pulmonary Arterial Hypertension |
Cereno Scientific AB |
2022-05-05 | PHASE2 |
| NCT06084533 | Enrolling by invitation | Parkinson Disease |
Washington University School of Medicine |
2024-01-10 | -- |
| NCT04541368 | NOT_YET_RECRUITING | Relapse Multiple Myeloma |
Zhejiang University |
2020-12-31 | EARLY_PHASE1 |
| NCT04662099 | UNKNOWN | CS1+ or BCMA+ Multiple Myeloma |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2020-03-25 | PHASE1 |
| NCT04864522 | WITHDRAWN | Multiple Myeloma |
University of Virginia |
2023-08 | PHASE1; PHASE2 |
| NCT05456269 | WITHDRAWN | Acute Myeloid Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Higher Risk Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia |
Racura Oncology Ltd |
2022-07-29 | PHASE1 |
| NCT04142619 | TERMINATED | Relapsed/Refractory Multiple Myeloma |
Cellectis S.A. |
2019-11-21 | PHASE1 |
| NCT06129838 | Recruiting | Alzheimer Disease |
Washington University School of Medicine |
2023-05-05 | -- |
| NCT03778346 | UNKNOWN | RRMM |
The Sixth Affiliated Hospital of Wenzhou Medical University |
2018-11-15 | PHASE1 |
| NCT04156269 | UNKNOWN | Multiple Myeloma |
iCell Gene Therapeutics |
2018-08-31 | EARLY_PHASE1 |
| NCT04517552 | Active not recruiting | Alzheimer Disease |
Tammie L. S. Benzinger MD PhD|Washington University School of Medicine |
2020-11-02 | -- |
| NCT03820908 | COMPLETED | Acute Myelogenous Leukemia; Allogeneic Stem Cell Transplantation |
Sheba Medical Center |
2019-07-18 | PHASE2 |
| NCT03477734 | COMPLETED | Atrium; Fibrillation |
CardiacSense Ltd. |
2019-02-20 | |
| NCT04142619 | Terminated | Relapsed/Refractory Multiple Myeloma |
Cellectis S.A. |
2019-11-21 | Phase 1 |
| NCT02907229 | COMPLETED | Intracranial Aneurysm |
National Cerebral and Cardiovascular Center, Japan |
2016-05 | |
| NCT02203825 | COMPLETED | Acute Myeloid Leukemia; Myelodysplastic Syndrome; Multiple Myeloma |
Celyad Oncology SA |
2015-03 | PHASE1 |
| NCT03903302 | COMPLETED | Thrombosis |
Cereno Scientific AB |
2017-10-06 | PHASE1 |
| NCT00742560 | COMPLETED | Hematologic Cancer |
AbbVie (prior sponsor, Abbott) |
2008-08 | PHASE2 |
| NCT01441973 | COMPLETED | Smoldering Multiple Myeloma |
Bristol-Myers Squibb |
2011-12-28 | PHASE2 |
| NCT01780246 | COMPLETED | Spinal Muscular Atrophy |
Biogen |
2013-01-31 | PHASE1 |
| NCT00726869 | TERMINATED | Multiple Myeloma |
Abbott |
2008-05 | PHASE1 |
| NCT00425347 | COMPLETED | Multiple Myeloma |
Facet Biotech |
2006-12 | PHASE1 |
| NCT00502645 | COMPLETED | Hyperglycemia; Critically Ill Patients |
Medical University of Graz |
2007-04 |
(data from https://clinicaltrials.gov, updated on 2026-07-09)
Check the
Bisantrene (CS1)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.