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Therapy Name Busulfan + Filgrastim + Fludarabine + Melphalan + MGTA-456 + Mycophenolate mofetil + Tacrolimus
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Busulfan Busulfex Busulphan Busulfex (busulfan) inhibits DNA replication and RNA transcription, likely through induction of DNA alkylation (PMID: 27481448). Busulfex (busulfan) in combination with cyclophosphamide is FDA approved as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for patients with chronic myelogenous leukemia (FDA.gov).
Filgrastim Neupogen G-CSF Neupogen (filgrastim) is a recombinant analog of granulocyte colony-stimulating factor (G-CSF) isoform B, which binds and activates G-CSF receptors modulating neutrophilic granulocyte progenitor activity, production, and differentiation (NCI Drug Dictionary).
Fludarabine Fludara FAMP|Fludarabine phosphate Flurdara (fludarabine) is converted to 2-fluoro-ara-ATP intracellularly, which potentially inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, leading to decreased DNA synthesis and reduced tumor growth (NCI Drug Dictionary)
MGTA-456 MGTA 456|Spanlecortemlocel|HSC835 MGTA-456 consists of a preparation of a cord blood cells expanded with an aryl hydrocarbon receptor antagonist, which may result in improved microglial engraftment and immune recovery (Neurology Apr 2019, 92 (15 Supplement) S51.001).
Melphalan Alkeran Chemotherapy - Alkylating 18 Alkeran (melphalan) is an antineoplastic alkylating agent, which cross-links DNA and induces cell toxicity and is FDA approved for multiple myeloma and epithelial ovarian carcinoma (FDA.gov).
Mycophenolate mofetil Cellcept RS-61443 Cellcept (mycophenolate mofetil) is metabolized to mycophenolic acid, which interferes with proliferation of B- and T-lymphocytes, resulting in immunosuppresion (PMID: 32228535).
Tacrolimus Hecoria FK-506|Prograf|Advagraf Tacrolimus binds to FKBP-12 and inhibits calcineurin activity, resulting in immunosuppression (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03674411 Phase II Busulfan + Filgrastim + Fludarabine + Melphalan + MGTA-456 + Mycophenolate mofetil + Tacrolimus Cyclophosphamide + Filgrastim + Fludarabine + MGTA-456 + Mycophenolate mofetil + Tacrolimus Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy Active, not recruiting USA 0


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