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Vaccine Response With NT-I7

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04054752
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : September 17, 2021
NeoImmuneTech, Inc.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Phase 1: Safety of NT-I7 in elderly patients after chemotherapy [ Time Frame: 28 days after treatment ]
    List of adverse events and frequency

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Age greater than or equal to 60 years
  • Documentation of positive diagnosis based on pathology/histology report (no need for archival tissue or new biopsy) for any of the following:

    • Stage I-III breast carcinoma following neo-adjuvant/adjuvant chemotherapy and appropriate surgery and/or radiotherapy.
    • Stage II or III gastrointestinal cancer following appropriate surgery and adjuvant chemotherapy or following appropriate neoadjuvant chemoradiation/surgery and adjuvant chemotherapy.
    • Stage II or III bladder carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant chemotherapy.
    • Stage IV breast, gastrointestinal, or prostate cancer, following surgery and chemotherapy, or chemotherapy alone

NOTE: "Appropriate therapy" for each disease must be consistent with NCCN Clinical Practice Guidelines in Oncology available at the time of treatment in the opinion of the investigator (

  • Completed cancer specific therapy (including surgery, radiotherapy and/or systemic therapy) at least 4 weeks and no more than 12 months prior to registration. (Subjects with hormone receptor positive breast carcinoma maintained on hormonal therapy following chemotherapy and radiation are eligible. Subjects with HER2 positive breast carcinoma maintained on anti-HER2 agents after definitive therapies are also eligible).
  • Reasonable expectation that no cancer-specific therapy, with the exception noted in the previous criteria, will be given in the subsequent 6 months (PI's discretion).
  • Adequate organ function, as follows:

    • AST/ALT: < 3 times upper limit of normal (ULN)
    • Bilirubin: < 1.5 times ULN
    • Absolute Neutrophil Count: > 1000/mm3
    • Platelet count: > 75,000/mm3
    • INR/PTT: <1.5 times ULN
    • Serum Creatinine: <1.5 times ULN
    • CPK: <2.5 times ULN
    • Serum albumin: greater than or equal to 3g/dL
    • Serum electrolytes: within normal limits
  • Karnofsky performance status greater or equal to 70%
  • Effects of NT-I7 on the developing human fetus are unknown. For these reasons the following measures apply:

    • Subjects enrolled on the study must not be planning to father children within the projected duration of the trial, starting with the pre-screening/screening visit through 90 days after the administration of NT-I7.
    • Men with partners of childbearing potential (defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal (i.e., amenorrheic for greater than or equal to 12 months without alternative medical cause) must use effective contraception prior to study entry, and for 90 days after the administration of NT-I7.
    • Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the study participants' treating physician should be informed immediately.


  • Subjects who are receiving any other investigational agents
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Significant heart disease defined as:

    • Significant coronary arterial disease
    • Myocardial infarction in the last 6 months, angina in the previous 3 months
    • Troponin elevation above reference range set by each institution where the troponin measurement was performed.
    • Ischemic changes on ECG
    • Atrio-ventricular block greater than 1st degree, in absence of pacemaker
    • QTc (using Fridericia and Framingham correction formula) greater than 480ms (CTCAE 5.0 grade 1 abnormality is acceptable)
    • History of ventricular arrhythmia
    • Left Ventricular Ejection Fraction of less than 50% determined by echocardiography
  • Positive serology for HTLV-I or HIV, or serology findings indicative of ongoing infection with hepatitis A, hepatitis B, or hepatitis C. Subjects with serology findings indicative of previous exposure to hepatitis A or B vaccination will not be excluded from Phase 1 part of the study but will be excluded from Phase 1b part of the study (see below for additional exclusion criteria for the Phase-1b part of the study only).
  • History of autoimmune disease EXCEPT for the following: subjects with vitiligo or endocrine disease controlled by replacement therapy including diabetes, thyroid, and adrenal disease may be enrolled
  • Subjects requiring chronic immunosuppressive therapy (including corticosteroids above physiologic replacement dosage) for any medical condition. We will permit 1) systemic corticosteroids at physiologic replacement dosage which are not to exceed 10 mg/day of prednisone or an equivalent, 2) intranasal or inhaled corticosteroids, 3) intraarticular injection of corticosteroids, 4) topical corticosteroids, 5) or a short-term use of systemic corticosteroids greater than 10 mg/day of prednisone or an equivalent for 10 days or less.
  • Splenomegaly or history of proliferative hematologic disease
  • Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
  • History of medical or psychiatric disease, or cognitive impairment, which, in the view of the principal investigator would preclude safe treatment
  • Serious bleeding diathesis based on clinical history of significant bleeding attributed to coagulation/bleeding disorders, documentation of abnormal coagulation factors/platelet function studies at the discretion of PI, or those who are on therapeutic anticoagulation
  • Inability to give informed consent
  • Subjects who have received immune checkpoint inhibitors in the previous 12 months, or subjects who have received immunomodulatory drugs in the previous 4 weeks for any medical indications. Subjects who have received intravesical BCG administration for non-muscle invasive bladder cancer will be included in this study (i.e., not one of exclusion criteria).
  • Additional exclusion criteria for the Phase-1b part of the study only are as follows:

    • Known hypersensitivity to any of the following: diphtheria toxoid, neomycin, polymixin B, streptomycin, 2 phenoxyethanol, formaldehyde, aluminum hydroxide, yeast
    • Previous exposure to Hepatitis A or B vaccines or history of hepatitis A or B infection
    • Subjects who received a Td or Tdap immunization in the previous 5 years
    • History of anaphylaxis or serious allergic reactions to previous administration of any of the vaccines
    • Subjects who had received one or more doses of the PPSV23 vaccine in the previous 12 months
    • Latex allergy
    • A history of Guillain-Barre syndrome within six weeks of administration of previous tetanus toxoid containing vaccines.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04054752

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Contact: Ronald E Gress, M.D. (240) 760-6167

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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      
Sponsors and Collaborators
National Cancer Institute (NCI)
NeoImmuneTech, Inc.
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Principal Investigator: Ronald E Gress, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT04054752    
Other Study ID Numbers: 190134
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: August 31, 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Breast Cancer
Colorectal Cancer
Immune Insufficiency
Bladder Cancer
Immunocompromised Host
Additional relevant MeSH terms:
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Breast Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs