Therapy Detail

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Therapy Name	Aldoxorubicin + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + Nogapendekin alfa inbakicept + PD-L1.t-haNK cells
Synonyms
Therapy Description

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Aldoxorubicin		INNO-206\|Doxorubicin-EMCH	Chemotherapy - Anthracycline 13	Aldoxorubicin (Doxorubicin-EMCH) is a derivative prodrug of doxorubicin that is converted to free doxorubicin within the acidic environment within tumors, and once converted, doxorubicin intercalates DNA, inhibits DNA synthesis and induces apoptosis (PMID: 30936721).
Cyclophosphamide	Cytoxan	CPM	Chemotherapy - Alkylating 18	Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary).
Gemcitabine	Gemzar	Difluorodeoxycytidine Hydrochlorothiazide\|LY-188011	Chemotherapy - Antimetabolite 14	Gemzar (gemcitabine) is converted in cells to difluorodeoxycytidine di- and triphosphate (dFdCDP, dFdCTP), which act to inhibit ribonucleoside reductase and as a deoxynucleotide analog respectively, resulting in DNA strand termination and apoptosis (NCI Drug Dictionary).
Nab-paclitaxel	Abraxane	ABI-007\|Paclitaxel Protein-bound	Chemotherapy - Taxane 3	Abraxane (nab-paclitaxel) is an albumin-stablized version of paclitaxel, which binds microtubules and prevents depolymerization, resulting in decreased cell motility and division (NCI Drug Dictionary).
Nogapendekin alfa inbakicept	Anktiva	N-803\|N803\|N 803\|nogapendekin alfa\|ALT803\|ALT 803\|ALT-803		Anktiva (nogapendekin alfa inbakicept) is a fusion protein comprising a mutant version of IL-15 with increased activity and IL-15Ra fused to the Fc region of IgG1, which activates CD8+ T-cells and promotes effector activity, potentially resulting in increased antitumor immune response (PMID: 24404427, PMID: 31338557). Anktiva (nogapendekin alfa inbakicept) in combination with BCG is FDA approved for use in patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors (FDA.gov).
PD-L1.t-haNK cells		PD-L1 t-haNK\|Allogeneic PD-L1-t-haNK		PD-L1.t-haNK cells are natural killer (NK) cells engineered to express a chimeric antigen receptor (CAR) that targets PD-L1, which may induce cell killing in PD-L1-expressing tumor cells resulting in decreased tumor growth (PMID: 32439799).

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT04390399	Phase II	Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Aldoxorubicin + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + Nogapendekin alfa inbakicept + PD-L1.t-haNK cells Aldoxorubicin + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + Nogapendekin alfa inbakicept	Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer	Active, not recruiting	USA	0

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