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NT-I7

DRUG8 trials

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, NeoImmuneTech, Washington University School of Medicine, National Institute of Neurological Disorders and Stroke (NINDS)

Conditions

Any Advanced Solid TumorsCOVID-19Cutaneous Squamous Cell CarcinomaGastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC)Large B-cell LymphomaLymphopeniaMalignant GliomaMelanoma

Early Phase 1

NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy
CompletedNCT04781309
National Institute of Neurological Disorders and Stroke (NINDS)Progressive Multifocal Leukoencephalopathy
Start: 2021-05-05End: 2025-11-07Updated: 2025-11-18

Phase 1

Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
TerminatedNCT02659800
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLymphopenia, Malignant Glioma
Start: 2018-10-30End: 2023-10-03Updated: 2023-10-06
High-Risk Skin Cancers With Atezolizumab Plus NT-I7
TerminatedNCT03901573
NeoImmuneTechCutaneous Squamous Cell Carcinoma, Melanoma, Merkel Cell Carcinoma
Start: 2019-12-26End: 2023-08-15Updated: 2025-10-22
NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
CompletedNCT04332653
NeoImmuneTechAny Advanced Solid Tumors, Microsatellite Stable Colorectal Cancer, Non Small Cell Lung Cancer +4
Start: 2020-06-10End: 2025-01-13Updated: 2026-03-09
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)
WithdrawnNCT04498325
Washington University School of MedicineCOVID-19, SARS-CoV-2
Start: 2021-07-31End: 2022-04-30Updated: 2021-08-05
NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma
TerminatedNCT04594811
NeoImmuneTechGastric or Gastro-esophageal Junction (GEJ) or Esophageal Adenocarcinoma (EAC)
Start: 2021-01-21End: 2023-05-26Updated: 2024-08-16
NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma
RecruitingNCT07052305
Washington University School of MedicineLarge B-cell Lymphoma
Start: 2026-03-12End: 2028-08-31Target: 24Updated: 2026-05-13
Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)
RecruitingNCT07200089
Washington University School of MedicineMultiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
Start: 2026-08-31End: 2028-12-31Target: 52Updated: 2026-07-21

Related Papers

A phase 2a study of NT-I7 (efineptakin alfa), a long-acting IL-7, and pembrolizumab to evaluate efficacy, including overall survival, in hard-to-treat gastrointestinal tumors.
Journal of Clinical Oncology2024-06-013 citations
Investigation of a potential protein biomarker signature that may predict clinical benefit of NT-I7 and pembrolizumab in patients with cold gastrointestinal tumors.
Journal of Clinical Oncology2024-06-01
652 NT-I7 (efineptakin alfa), a long-acting IL-7, in combination with pembrolizumab improves T cell fitness in heavily pretreated subjects with gastrointestinal tumors
Regular and Young Investigator Award Abstracts2023-10-311 citations
657 NT-I7, a long-acting IL-7, plus pembrolizumab favors CD8 T-cell infiltration in liver metastases of heavily pre-treated, immunologically cold, MSS-colorectal and pancreatic cancer
Regular and Young Investigator Award Abstracts2022-11-013 citations
A phase 1b/2a study of safety and efficacy of NT-I7 in combination with anti-PD-L1 (atezolizumab) in patients with anti-PD-1/PD-L1 naïve or relapsed/refractory (R/R) high-risk skin cancers: The phase 1b report.
Journal of Clinical Oncology2022-06-016 citations
Efficacy and safety of NT-I7, long-acting interleukin-7, plus pembrolizumab in patients with advanced solid tumors: Results from the phase 2a study.
Journal of Clinical Oncology2022-06-015 citations
404 Initial biomarker and clinical data of a phase 2a study of NT-I7, a long-acting interleukin-7, plus pembrolizumab: cohort of subjects with checkpoint inhibitor-naïve advanced MSS-colorectal cancer
Regular and Young Investigator Award Abstracts2021-11-016 citations
408 Preliminary biomarker and clinical ata of a phase 2a study of NT-I7, a long-acting interleukin-7, plus pembrolizumab: cohort of subjects with checkpoint inhibitor-naïve advanced pancreatic cancer
Regular and Young Investigator Award Abstracts2021-11-014 citations
Safety, pharmacokinetics, pharmacodynamics profiles and preliminary antitumor activity of phase 1b/2a study of NT-I7, a long-acting interleukin-7, plus pembrolizumab in patients with advanced solid tumors: The phase 1b data report.
Journal of Clinical Oncology2021-05-203 citations