Therapy Detail

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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)
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).
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).
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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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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