Genexine Trials - LARVOL Sigma

44 Trials

Active Trials

Export

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma

NCT04155125: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

Completed

391

RoW

efepoetin alfa, Mircera

PT Kalbe Genexine Biologics, Novotech (Australia) Pty Limited

Anaemia Associated With Chronic Kidney Disease

03/22

06/23

NCT06466785: A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Recruiting

429

RoW

Efepoetin Alfa, GX-E4, Darbepoetin Alfa, Aranesp®

Genexine, Inc., PT Kalbe Genexine Biologics

Anemia of Chronic Kidney Disease

12/26

09/27

GX-E4-HV-003, NCT06490939: Clinical Trial of Efepoetin Alfa in Healthy Subjects

Recruiting

RoW

Efepoetin Alfa, GX-E4

Genexine, Inc.

Healthy

02/25

10/25

Papitrol (tirvalimogene teraplasmid) / Genexine, National OncoVenture

GENUINE, NCT05286060: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer

Recruiting

RoW

GX-188E, GX-I7, Pembrolizumab, GX-188E, Pembrolizumab, GX-188E, GX-I7

Yonsei University, Genexine, Inc., NeoImmuneTech

Head and Neck Squamous Cell Carcinoma

08/25

12/25

TRINITY, NCT05280457: HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy

Recruiting

RoW

nivolumab-GX-188E-GX-I7

Yonsei University

Head and Neck Squamous Cell Carcinoma

03/26

KEYNOTE-567, NCT03444376: The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer

Completed

1/2

RoW

GX-188E, Ichor Tri-Grid Delivery System, KEYTRUDA®, pembrolizumab

Genexine, Inc., Merck Sharp & Dohme LLC

Cervical Cancer

04/22

12/23

eftansomatropin alfa (GX-H9) / Genexine

NCT04633057: A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency

Completed

168

RoW

TJ101, NordiFlex

TJ Biopharma Co., Ltd.

Pediatric Growth Hormone Deficiency

07/23

Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech

NCT04810637: A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19

Recruiting

210

RoW

GX-I7, Efineptakin alfa NT-I7, rhIL-7-hyFc, NT-I7, TJ107

PT Kalbe Genexine Biologics, Genexine, Inc.

Covid19

06/21

09/21

NCT05145907: Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors

Active, not recruiting

133

RoW

TJ107 +Pembrolizumab

TJ Biopharma Co., Ltd.

Triple-negative Breast Cancer, Head and Neck Squamous Cell Carcinoma

06/24

12/24

NCT04600817: A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT)

Active, not recruiting

160

RoW

TJ107, TJ107 placebo

TJ Biopharma Co., Ltd.

Newly Diagnosed Glioblastoma

12/24

NCT04984811: NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

Active, not recruiting

efineptakin alfa, NT-I7, Atezolizumab, Tecentriq

NeoImmuneTech, Roche Pharma AG

Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer

09/24

03/25

NCT05465954: Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

Recruiting

Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Efineptakin alfa, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc, TJ 107, TJ-107, TJ107, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Biopsy, BIOPSY_TYPE, Bx

Mayo Clinic, NeoImmuneTech, Merck Sharp & Dohme LLC, National Cancer Institute (NCI)

High Grade Astrocytic Tumor, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma

10/27

10/28

NCT05191784: GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

Active, not recruiting

RoW

GX-I7, rhIL-7-hyFc, Efineptakin alfa, Bevacizumab, Avastin

Genexine, Inc.

Recurrent Glioblastoma

12/24

KEYNOTE-899, NCT03752723: Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/)

Completed

1/2

RoW

GX-I7, Efineptakin alfa, Pembrolizumab(KEYTRUDA®), KEYTRUDA®, MK-3745, Cyclophosphamide

Genexine, Inc., Merck Sharp & Dohme LLC

Triple Negative Breast Cancer

05/23

NCT03901573: High-Risk Skin Cancers With Atezolizumab Plus NT-I7

Terminated

1/2

NT-I7, efineptakin alfa, rhIL-7-hyFc, atezolizumab, Tecentriq

NeoImmuneTech, Immune Oncology Network

Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma

08/23

KEYNOTE A60, NCT04332653: NT-I7 (Efineptakin Alfa) in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Active, not recruiting

1/2

215

NT-I7, Efineptakin alfa, rhIL-7-hyFc, pembrolizumab (KEYTRUDA®), KEYTRUDA®

NeoImmuneTech, Merck Sharp & Dohme LLC

Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer

11/24

12/24

NCT05600920: A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia

Recruiting

1/2

Recombinant human interleukin (IL) 7-hyFc

National Institute of Allergy and Infectious Diseases (NIAID), NeoImmuneTech

Idiopathic CD4 Lymphopenia

11/26

NCT03687957: rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide

Active, not recruiting

1/2

rhIL-7-hyFc, Placebo, Temozolomide, TMZ, Radiation therapy, RT, Blood sample

Washington University School of Medicine, NeoImmuneTech, The Foundation for Barnes-Jewish Hospital

Glioma

09/25

01/32

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)

Not yet recruiting

NT-17, Placebo, Supportive care, Peripheral blood draw

Washington University School of Medicine

COVID-19, SARS-CoV-2

02/21

NCT04501796: A Trial of NT-I7 in COVID-19 (SPESELPIS)

Terminated

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

Recruiting

Recombinant human interleukin 7-hyFc, Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

SARs CoV 2

12/21

NCT02659800: Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas

Terminated

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

NCT06344715: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.

Recruiting

RoW

SL-T10, GX-I7, Pembrolizumab

SL VAXiGEN

Metastatic Castration-resistant Prostate Cancer (mCRPC)

10/24

NCT04594811 / 2020-004175-41: NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma

Terminated

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

NCT04054752: Vaccine Response With NT-I7

Withdrawn

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

NCT04893018: NT-I7 for Kaposi Sarcoma in Patients With or Without HIV

Terminated

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

NCT04588038: NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

Terminated

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

02/25

NCT05075603: Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy

Recruiting

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

NCT07052305: NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma

Not yet recruiting

NT-17, Efineptakin alfa, CAR T-cell therapy

Washington University School of Medicine, NeoImmuneTech

Large B-cell Lymphoma

07/27

04/28

NCT04781309: NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy

Recruiting

NT-I7

National Institute of Neurological Disorders and Stroke (NINDS), NeoImmuneTech

Progressive Multifocal Leukoencephalopathy

01/26

NCT04289155: Individual Patient Compassionate Use of GX-I7

No Longer Available

N/A

RoW

GX-I7

Genexine, Inc.

Glioblastoma, High Grade Glioma, Recurrent Glioblastoma, Melanoma, Advanced Cancer

GX-G6 / Genexine

SYSA1803-010, NCT06258148: Phase 3 Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus

Not yet recruiting

300

TG103, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

03/26

11/26

NCT06235086: Phase 3 Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

Not yet recruiting

618

RoW

TG103, Dulaglutide

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

03/26

11/26

NCT05997576: A Study of TG103 Injection in Non-diabetic Overweight or Obesity

Not yet recruiting

675

RoW

TG103 22.5 mg, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Overweight or Obesity

01/25

04/25

ChiCTR2100051312: A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes

Not yet recruiting

186

TG103 (15 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes combined with overweight/obesity. ;TG103 (22.5 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes combined with overweight/obesity. ;TG103 (30 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes combined with overweight/obesity. ;Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes will be administered via subcutaneous injection once weekly.

Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University; Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University, CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes

NCT05299697: A Study of TG103 Injection in Overweight or Obesity

Recruiting

195

RoW

TG103 15 mg, TG103 22.5 mg, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Overweight or Obesity

06/23

09/23

NCT05348122: A Study of TG103 Injection in Type 2 Diabetes Subjects

Not yet recruiting

240

RoW

TG103,Q2W, TG103 injection, subcutaneous injection,Q2W, TG103,QW, TG103 injection, subcutaneous injection,QW, Placebo,Q2W, Placebo, subcutaneous injection,Q2W, Placebo,QW, Placebo, subcutaneous injection,QW, Dulaglutide,QW, Dulaglutide,subcutaneous injection,QW

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

11/23

NCT06226090: A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity

Completed

314

RoW

TG103 7.5 mg, Placebo 7.5 mg, TG103 15 mg, Placebo 15 mg, TG103 22.5 mg, Placebo 22.5 mg

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Obesity, Overweight

09/24

10/24

NCT05063253: A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes

Not yet recruiting

208

TG103, Administered SC, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

03/24

NCT04790006: A Study of TG103 in Subjects With Type 2 Diabetes

Not yet recruiting

TG103, Placebo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Type 2 Diabetes

03/22

NCT04855292: A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes

Completed

RoW

TG103 injection, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Diabetes

12/22

01/23

GX-19N / Genexine, Binex, GenNBio, PT Kalbe Farma

NCT04715997: Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults

Active, not recruiting

1/2

170

RoW

GX-19N, Dose A, Placebo, Normal saline

Genexine, Inc.

SARS-CoV-2

07/21

06/22

NCT04445389: Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults

Active, not recruiting

1/2

RoW

GX-19, DNA vaccine expressing SARS-CoV-2 S-protein antigen, Saline

Genexine, Inc.

SARS-CoV-2

12/21

03/22

NCT04915989: Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals

Completed

RoW

GX-19N, Dose A

Genexine, Inc.

SARS-CoV-2

04/22

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma

NCT04155125: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

Completed

391

RoW

efepoetin alfa, Mircera

PT Kalbe Genexine Biologics, Novotech (Australia) Pty Limited

Anaemia Associated With Chronic Kidney Disease

03/22

06/23

NCT06466785: A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Recruiting

429

RoW

Efepoetin Alfa, GX-E4, Darbepoetin Alfa, Aranesp®

Genexine, Inc., PT Kalbe Genexine Biologics

Anemia of Chronic Kidney Disease

12/26

09/27

GX-E4-HV-003, NCT06490939: Clinical Trial of Efepoetin Alfa in Healthy Subjects

Recruiting

RoW

Efepoetin Alfa, GX-E4

Genexine, Inc.

Healthy

02/25

10/25

Papitrol (tirvalimogene teraplasmid) / Genexine, National OncoVenture

GENUINE, NCT05286060: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer

Recruiting

RoW

GX-188E, GX-I7, Pembrolizumab, GX-188E, Pembrolizumab, GX-188E, GX-I7

Yonsei University, Genexine, Inc., NeoImmuneTech

Head and Neck Squamous Cell Carcinoma

08/25

12/25

Recruiting

RoW

nivolumab-GX-188E-GX-I7

Yonsei University

Head and Neck Squamous Cell Carcinoma

03/26

KEYNOTE-567, NCT03444376: The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer

Completed

1/2

RoW

GX-188E, Ichor Tri-Grid Delivery System, KEYTRUDA®, pembrolizumab

Genexine, Inc., Merck Sharp & Dohme LLC

Cervical Cancer

04/22

12/23

eftansomatropin alfa (GX-H9) / Genexine

NCT04633057: A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency

Completed

168

RoW

TJ101, NordiFlex

TJ Biopharma Co., Ltd.

Pediatric Growth Hormone Deficiency

07/23

Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech

NCT04810637: A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19

Recruiting

210

RoW

GX-I7, Efineptakin alfa NT-I7, rhIL-7-hyFc, NT-I7, TJ107

PT Kalbe Genexine Biologics, Genexine, Inc.

Covid19

06/21

09/21

NCT05145907: Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors

Active, not recruiting

133

RoW

TJ107 +Pembrolizumab

TJ Biopharma Co., Ltd.

Triple-negative Breast Cancer, Head and Neck Squamous Cell Carcinoma

06/24

12/24

NCT04600817: A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT)

Active, not recruiting

160

RoW

TJ107, TJ107 placebo

TJ Biopharma Co., Ltd.

Newly Diagnosed Glioblastoma

12/24

NCT04984811: NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

Active, not recruiting

efineptakin alfa, NT-I7, Atezolizumab, Tecentriq

NeoImmuneTech, Roche Pharma AG

Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer

09/24

03/25

NCT05465954: Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

Recruiting

Mayo Clinic, NeoImmuneTech, Merck Sharp & Dohme LLC, National Cancer Institute (NCI)

High Grade Astrocytic Tumor, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma

10/27

10/28

NCT05191784: GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients

Active, not recruiting

RoW

GX-I7, rhIL-7-hyFc, Efineptakin alfa, Bevacizumab, Avastin

Genexine, Inc.

Recurrent Glioblastoma

12/24

KEYNOTE-899, NCT03752723: Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/)

Completed

1/2

RoW

GX-I7, Efineptakin alfa, Pembrolizumab(KEYTRUDA®), KEYTRUDA®, MK-3745, Cyclophosphamide

Genexine, Inc., Merck Sharp & Dohme LLC

Triple Negative Breast Cancer

05/23

NCT03901573: High-Risk Skin Cancers With Atezolizumab Plus NT-I7

Terminated

1/2

NT-I7, efineptakin alfa, rhIL-7-hyFc, atezolizumab, Tecentriq

NeoImmuneTech, Immune Oncology Network

Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma

08/23

KEYNOTE A60, NCT04332653: NT-I7 (Efineptakin Alfa) in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Active, not recruiting

1/2

215

NT-I7, Efineptakin alfa, rhIL-7-hyFc, pembrolizumab (KEYTRUDA®), KEYTRUDA®

NeoImmuneTech, Merck Sharp & Dohme LLC

Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer

11/24

12/24

NCT05600920: A Single-arm, Dose-escalation Trial of Long-acting Recombinant Human IL-7 (NT-I7, Efineptakin Alfa) for Idiopathic CD4 Lymphopenia

Recruiting

1/2

Recombinant human interleukin (IL) 7-hyFc

National Institute of Allergy and Infectious Diseases (NIAID), NeoImmuneTech

Idiopathic CD4 Lymphopenia

11/26

NCT03687957: rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide

Active, not recruiting

1/2

rhIL-7-hyFc, Placebo, Temozolomide, TMZ, Radiation therapy, RT, Blood sample

Washington University School of Medicine, NeoImmuneTech, The Foundation for Barnes-Jewish Hospital

Glioma

09/25

01/32

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)

Not yet recruiting

NT-17, Placebo, Supportive care, Peripheral blood draw

Washington University School of Medicine

COVID-19, SARS-CoV-2

02/21

NCT04501796: A Trial of NT-I7 in COVID-19 (SPESELPIS)

Terminated

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

Recruiting

Recombinant human interleukin 7-hyFc, Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

SARs CoV 2

12/21

NCT02659800: Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas

Terminated

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

NCT06344715: Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.

Recruiting

RoW

SL-T10, GX-I7, Pembrolizumab

SL VAXiGEN

Metastatic Castration-resistant Prostate Cancer (mCRPC)

10/24

NCT04594811 / 2020-004175-41: NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma

Terminated

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

NCT04054752: Vaccine Response With NT-I7

Withdrawn

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

NCT04893018: NT-I7 for Kaposi Sarcoma in Patients With or Without HIV

Terminated

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

NCT04588038: NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

Terminated

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

02/25

NCT05075603: Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy

Recruiting

Efineptakin alfa, NT-I7, rhIL-7-hyFc, Tisagenlecleucel, Kymriah, Axicabtagene ciloleucel, Yescarta, Lisocabtagene Maraleucel, Breyanzi

NeoImmuneTech

11/24

02/26

Not yet recruiting

NT-17, Efineptakin alfa, CAR T-cell therapy

Washington University School of Medicine, NeoImmuneTech

Large B-cell Lymphoma

07/27

04/28

NCT04781309: NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy

Recruiting

NT-I7

National Institute of Neurological Disorders and Stroke (NINDS), NeoImmuneTech

Progressive Multifocal Leukoencephalopathy

01/26

NCT04289155: Individual Patient Compassionate Use of GX-I7

No Longer Available

N/A

RoW

GX-I7

Genexine, Inc.

Glioblastoma, High Grade Glioma, Recurrent Glioblastoma, Melanoma, Advanced Cancer

GX-G6 / Genexine

SYSA1803-010, NCT06258148: Phase 3 Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus

Not yet recruiting

300

TG103, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

03/26

11/26

NCT06235086: Phase 3 Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

Not yet recruiting

618

RoW

TG103, Dulaglutide

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

03/26

11/26

NCT05997576: A Study of TG103 Injection in Non-diabetic Overweight or Obesity

Not yet recruiting

675

RoW

TG103 22.5 mg, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Overweight or Obesity

01/25

04/25

ChiCTR2100051312: A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes

Not yet recruiting

186

Type 2 Diabetes

NCT05299697: A Study of TG103 Injection in Overweight or Obesity

Recruiting

195

RoW

TG103 15 mg, TG103 22.5 mg, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Overweight or Obesity

06/23

09/23

NCT05348122: A Study of TG103 Injection in Type 2 Diabetes Subjects

Not yet recruiting

240

RoW

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

11/23

NCT06226090: A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity

Completed

314

RoW

TG103 7.5 mg, Placebo 7.5 mg, TG103 15 mg, Placebo 15 mg, TG103 22.5 mg, Placebo 22.5 mg

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Obesity, Overweight

09/24

10/24

NCT05063253: A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes

Not yet recruiting

208

TG103, Administered SC, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Type 2 Diabetes Mellitus

03/24

NCT04790006: A Study of TG103 in Subjects With Type 2 Diabetes

Not yet recruiting

TG103, Placebo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Type 2 Diabetes

03/22

NCT04855292: A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes

Completed

RoW

TG103 injection, Placebo

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Diabetes

12/22

01/23

GX-19N / Genexine, Binex, GenNBio, PT Kalbe Farma

NCT04715997: Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults

Active, not recruiting

1/2

170

RoW

GX-19N, Dose A, Placebo, Normal saline

Genexine, Inc.

SARS-CoV-2

07/21

06/22

NCT04445389: Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults

Active, not recruiting

1/2

RoW

GX-19, DNA vaccine expressing SARS-CoV-2 S-protein antigen, Saline

Genexine, Inc.

SARS-CoV-2

12/21

03/22

NCT04915989: Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals

Completed

RoW

GX-19N, Dose A

Genexine, Inc.

SARS-CoV-2

04/22

Download Options



	Diseases Companies Products Productz Mechanisms of Action Sites