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Therapy Name	Nogapendekin alfa inbakicept
Synonyms
Therapy Description	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).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
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).

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT01885897	Phase Ib/II	Nogapendekin alfa inbakicept	IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT	Completed	USA	0
NCT01946789	Phase I	Nogapendekin alfa inbakicept	A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors	Completed	USA	0
NCT02890758	Phase I	Nogapendekin alfa inbakicept	Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803	Completed	USA	0
NCT02989844	Phase II	Nogapendekin alfa inbakicept	QUILT-3.035: Relapse Prophylaxis With ALT-803 for AML and MDS Pts Following Allo HSCT	Completed	USA	0
NCT03054909	Phase I	Nogapendekin alfa inbakicept	QUILT-2.021: Phase I of IP Followed by SQ ALT-803 for Ovarian Cancer	Completed	USA	0
NCT02099539	Phase Ib/II	Nogapendekin alfa inbakicept	A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma	Terminated	USA	0
NCT03136406	Phase Ib/II	GI-4000 Leucovorin Avelumab Nab-paclitaxel Bevacizumab Cyclophosphamide Capecitabine Oxaliplatin Fluorouracil ETBX-011 Nogapendekin alfa inbakicept	QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy	Terminated	USA	0
NCT03387085	Phase Ib/II	ETBX-051 Aldoxorubicin ETBX-061 Cisplatin Cyclophosphamide haNK cells GI-4000 Bevacizumab Nogapendekin alfa inbakicept Fluorouracil ETBX-011 Oxaliplatin Capecitabine Leucovorin GI-6301 Nab-paclitaxel Avelumab GI-6207	QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.	Terminated	USA	0
NCT03387098	Phase Ib/II	GI-4000 Leucovorin Nab-paclitaxel Bevacizumab Avelumab Nogapendekin alfa inbakicept Fluorouracil ETBX-011 Oxaliplatin Aldoxorubicin Capecitabine Cyclophosphamide	QUILT-3.070: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy	Terminated	USA	0
NCT03387111	Phase Ib/II	Capecitabine Nab-paclitaxel Leucovorin GI-6301 GI-6207 Avelumab ETBX-021 ETBX-051 ETBX-061 Aldoxorubicin Cisplatin Cyclophosphamide Bevacizumab Necitumumab GI-4000 Cetuximab Nogapendekin alfa inbakicept Fluorouracil ETBX-011	Molecularly Informed Integrated Immunotherapy Combining Innate haNK Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti- PD-1/ PD-L1 Therapy	Terminated	USA	0
NCT03365661	Phase II	Nogapendekin alfa inbakicept	QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML	Withdrawn	USA	0
NCT05445882	Phase II	Bintrafusp alfa + Nogapendekin alfa inbakicept Nogapendekin alfa inbakicept	N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer	Withdrawn	USA	0

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