Vaccine Response With NT-I7
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|ClinicalTrials.gov Identifier: NCT04054752|
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : September 17, 2021
People with cancer, and especially older people, have a weakened immune system (the defense system of the body). This is often caused by the treatments for cancer. Older cancer survivors are therefore more prone to getting infections, some of which are preventable through vaccines. But because their immune systems are weakened, their response to vaccines is poor. Researchers want to see if a new drug, NT-I7, can help.
To see if NT-I7 can boost the immune system.
Adults 60 and older who have recently finished chemotherapy for breast, colorectal, or bladder cancer.
Participants will be screened with a physical exam, medical history, and blood and urine samples. Their heart s electrical activity will be checked. They will have an ultrasound of their spleen. They may give a tissue sample from a previous biopsy.
Participants in phase 1a of the study will get 1 dose of NT-I7. It will be given by injection with a needle into the muscle of the upper arm, thigh, or buttocks.
Participants in phase 1b will get 5 vaccines over a few months. They may get an optional booster and/or 6th vaccine. They will also get NT-I7.
Participants will repeat the screening tests during the study. They may get a peripheral intravenous catheter in a vein in their hand or arm for blood draws.
Participants may have apheresis. For this, blood is taken from an arm vein. The white blood cells are separated from the blood. The rest of the blood, minus the white blood cells, is returned into a vein in the other arm. A catheter may be used.
Participants will have follow-up visits for 1 year.
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma Colorectal Adenocarcinoma Bladder Carcinoma||Biological: Recombinant human IL-7-hyFc (NT-I7) Biological: Vaccine sequence 1 Biological: Vaccine sequence 2||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/1b Study of Enhancement of Immune Reconstitution and Vaccine Responses With Administration of Recombinant Human IL-7-hyFc (NT-I7) in Older Subjects Following Chemotherapy|
|Estimated Study Start Date :||September 22, 2021|
|Estimated Primary Completion Date :||May 19, 2024|
|Estimated Study Completion Date :||May 19, 2025|
Experimental: 1/Arm 1
NT-I7 administered at 720 and 960g/kg to select the OBD of NT-I7
Biological: Recombinant human IL-7-hyFc (NT-I7)
NT-I7 administered at escalating doses of 720, and 960g/kg to determine OBD of NT-I7
Active Comparator: 2/Arm 2a
Administration of 4 vaccines according to Sequence 1 + NT-I7 administration at OBD to assess vaccine response
Biological: Vaccine sequence 1
Day 1 Immunization Pre-NT-I7:Td and Polio Day 64, Immunization Post-NT-I7: Hep A#1, Hep B#1 Day 106: Hep B#2 (Optional) 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2, Hep #3, PPSV23#1
Active Comparator: 3/Arm 2b
Administration of 5 vaccines according to Sequence 2 + NT-I7 administration at OBD to assess vaccine response
Biological: Vaccine sequence 2
Day 1 Immunization Pre-NT-I7: Hep A#1, Hep B#1 Day 64, Immunization Post-NT-I7:Td and Polio, PCV13 Day 106: no Vaccine 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2, Hep #3, PPSV23#1
- Phase 1: Safety of NT-I7 in elderly patients after chemotherapy [ Time Frame: 28 days after treatment ]List of adverse events and frequency
- Phase 1b: Evaluate and quantify if NT-I7 at optimal biological dose (OBD) has impacts on specific immune responses to vaccines [ Time Frame: day 42 and day 106 ]vaccine titers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054752
|Contact: Ronald E Gress, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Ronald E Gress, M.D.||National Cancer Institute (NCI)|