| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech |
NCT03478995: Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors |
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| Completed | 1b | 35 | RoW | GX-I7 | Genexine, Inc. | Locally Advanced or Metastatic Solid Tumors | 03/20 | 03/20 | | |
NCT03733587: GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors |
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| Completed | 1b | 24 | RoW | GX-I7, Cyclophosphamide, Endoxan | Genexine, Inc. | Solid Tumor | 04/20 | 05/20 | | |
GBM, NCT03619239: Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma |
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| Completed | 1b | 15 | RoW | GX-I7 | Genexine, Inc. | Newly Diagnosed Glioblastoma | 09/20 | 09/20 | | |
NCT04730427: Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19 |
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| Terminated | 1b | 10 | RoW | GX-I7, Efineptakin alfa, rhIL-7-hyFc, NT-I7, TJ107, GX-I7 vehicle | Genexine, Inc. | Covid19 | 05/22 | 07/22 | | |
| Completed | 1 | 30 | RoW | GX-I7, IL-7-hyFc, Placebo, GX-17 vehicle (formulation buffer) | Genexine, Inc. | Healthy | 01/17 | 06/18 | | |
NCT03144934: Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers |
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| Completed | 1 | 32 | RoW | GX-I7, IL-7-hyFc, Placebo, GX-I7 vehicle (formulation buffer) | Genexine, Inc. | Human Papillomavirus | 03/18 | 03/18 | | |
NCT04283695: To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers |
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| Unknown status | 1 | 12 | RoW | GX-I7 or [14C] GX-I7 | Seoul National University Hospital | Leukopenia | 08/19 | 05/20 | | |
NCT04380948: A Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Enhance Immune Clearance of SARS-CoV-2 (COVID-19) |
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| Not yet recruiting | 1 | 30 | US | NT-17, Placebo, Supportive care, Peripheral blood draw | Washington University School of Medicine | COVID-19, SARS-CoV-2 | 02/21 | 02/21 | | |
| Terminated | 1 | 7 | US | Double-Blind NT-I7, rhIL-7-hyFc, efineptakin alfa, Double-Blind Placebo | NeoImmuneTech, National Institute of Allergy and Infectious Diseases (NIAID), University of Nebraska | COVID-19 | 07/21 | 02/23 | | |
NCT04476290: A Double-Blind, Randomized, Placebo-Controlled, Phase 1, Single-Dose, Dose-Escalating Trial of Long-Acting Recombinant Human IL-7 (NT-I7) for COVID-19 |
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| Recruiting | 1 | 60 | US | Recombinant human interleukin 7-hyFc, Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | SARs CoV 2 | 12/21 | 12/21 | | |
NCT02659800: Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas |
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| Terminated | 1 | 12 | US | Laboratory Biomarker Analysis, NT-I7, Placebo | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, National Cancer Institute (NCI), NeoImmuneTech | Lymphopenia, Malignant Glioma | 03/22 | 10/23 | | |
NCT04498325: Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Increase Lymphocyte Counts and Enhance Immune Clearance of SARS-CoV-2 (COVID-19) |
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| Withdrawn | 1 | 0 | NA | NT-I7, Placebo, Blood for research purposes, Blood for pharmacokinetic samples, Nasopharyngeal, oropharyngeal, or saliva swab, Blood for anti-drug antibody (ADA) | Washington University School of Medicine, NeoImmune Tech | COVID-19, SARS-CoV-2 | 04/22 | 04/22 | | |
NCT06344715: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. |
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| Recruiting | 1 | 78 | RoW | SL-T10, GX-I7, Pembrolizumab | SL VAXiGEN | Metastatic Castration-resistant Prostate Cancer (mCRPC) | 10/24 | 10/24 | | |
| Terminated | 1 | 10 | Europe, US | NT-I7, Efineptakin alfa, rhIL-7-hyFc, Nivolumab | NeoImmuneTech, Bristol-Myers Squibb | Gastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC) | 05/23 | 05/23 | | |
| Withdrawn | 1 | 68 | US | Recombinant human IL-7-hyFc (NT-I7), Vaccine sequence 1, Vaccine sequence 2 | National Cancer Institute (NCI), NeoImmuneTech | Breast Carcinoma, Colorectal Adenocarcinoma, Bladder Carcinoma | 11/23 | 11/23 | | |
NCT04893018: NT-I7 for Kaposi Sarcoma in Patients With or Without HIV |
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| Terminated | 1 | 8 | US | Efineptakin alfa, 2026634-47-7, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc | Fred Hutchinson Cancer Center, Cancer Immunotherapy Trials Network (CITN), National Cancer Institute (NCI) | AIDS-Related Kaposi Sarcoma, HIV Infection, Kaposi Sarcoma | 12/23 | 12/23 | | |
NCT04588038: NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery |
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| Recruiting | 1 | 10 | US | Efineptakin alfa, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc, TJ 107, TJ-107, TJ107 | Hyunseok Kang, MD, NeoImmuneTech | Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Resectable Oropharyngeal Squamous Cell Carcinoma | 03/25 | 03/25 | | |
NCT05075603: Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy |
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| Recruiting | 1 | 57 | US | Efineptakin alfa, NT-I7, rhIL-7-hyFc, Tisagenlecleucel, Kymriah, Axicabtagene ciloleucel, Yescarta, Lisocabtagene Maraleucel, Breyanzi | NeoImmuneTech | Refractory Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent Diffuse Large B-Cell Lymphoma, Refractory High Grade B-Cell Lymphoma, Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma | 11/24 | 02/26 | | |
NCT04781309: NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy |
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| Recruiting | 1 | 12 | US | NT-I7 | National Institute of Neurological Disorders and Stroke (NINDS), NeoImmuneTech | Progressive Multifocal Leukoencephalopathy | 01/26 | 01/26 | | |
