Breast CarcinomaPhase 1NCT04054752
Vaccine Response With NT-I7
A Phase 1 study testing Recombinant human IL-7-hyFc (NT-I7), Vaccine sequence 1 and Vaccine sequence 2 in people with Breast Carcinoma and Colorectal Adenocarcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Breast Carcinoma, Colorectal Adenocarcinoma, Bladder Carcinoma
- What is being tested?
- Recombinant human IL-7-hyFc (NT-I7), Vaccine sequence 1 and Vaccine sequence 2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 1 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 (http://www.nccn.org/professionals/physiciangls/fguidelines.asp)
- 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 120 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 120 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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
Background:
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.
Read more
Objective:
To see if NT-I7 can boost the immune system.
Eligibility:
Adults 60 and older who have recently finished chemotherapy for breast, colorectal, or bladder cancer.
Design:
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.
Read the detailed description
Background:
Interleukin-7 is a homeostatic cytokine with a critical role in lymphoid homeostasis through which it exerts its immune-restorative effects, particularly re-expansion of the na(SqrRoot) ve and memory T-cell subsets.
The clinical implications of the kinetics, nature and extent of immune reconstitution defects following standard or ablative chemotherapy in older adults with cancer (in particular the lack of reconstitution of large pools of na(SqrRoot) ve T-cell with broad repertoire diversity and of memory T-cells) are not well characterized.
As chemotherapy often induces only temporary complete or partial disease responses but no cure, candidates for novel immunotherapy strategies may be significantly impeded in their responses to active immunotherapy attempts, the therapeutic potential of which is becoming increasingly utilized.
Recombinant human IL-7 (rhIL-7) may play a role in immune reconstitution and immune enhancement in various circumstances of immune insufficiency in older individuals following chemotherapy or in the context of enhancing cancer immunotherapy or during immune senescence.
Elderly cancer survivors are vulnerable to vaccine-preventable diseases and are known to have poor anti-vaccine-specific immune responses. Effective prevention of communicable diseases is important for cancer survivorship.
This study will use NT-I7, a long acting IL-7 cytokine, composed of human IL-7 and a hybrid Fc (hyFc) region to extend half-life.
Objectives:
Phase 1: Select optimal biological dose (OBD) of NT-I7 in older subjects with breast, bladder, prostate or a gastrointestinal cancer following chemotherapy.
Phase 1b: Evaluate and quantify the functional impact of NT-I7 therapy on specific immune responses to selected vaccines in older subjects following chemotherapy.
Eligibility:
Adults greater than or equal to 60 year of age.
Diagnosis of non-metastatic breast, bladder or a gastrointestinal cancer following adjuvant / neo-adjuvant chemotherapy; or metastatic breast, gastrointestinal or prostate cancer after chemotherapy.
Completed a treatment with chemotherapy a minimum of 4 weeks and no more than 12 months prior to entry with no evidence of disease.
Reasonable expectation that no cancer-specific therapy will be given in the subsequent 6 months.
Design:
Subjects will be enrolled into this single center Phase 1/1b study following the specific therapy for their respective diseases.
In Phase 1 part of the study, two dose levels, 720 micro g/kg and 960 micro g/kg, will be compared. Six subjects will be enrolled in each dose level, and a single dose of NT-I7 will be delivered intramuscularly. The purpose of this part of the study is to select the OBD.
OBD is defined as the dose that yields the greatest rise in peak absolute total T-cell counts (peak value at any timepoint during the first 28 days post NT-I7 administration) with corresponding rise in na(SqrRoot) ve subsets of CD4+ and CD8+ T cells without accompanying substantial toxicities. Absolute increase is a delta between the baseline counts and the peak counts within each subject.
Once OBD is determined, the Phase 1b portion of this study will begin. Subjects will undergo immunizations with various antigens, randomized to be administered either before or after a single dose of NT-I7 at OBD. This inter-subject randomization of the order in which the immunizations are administered (according to the Sequence 1 or to the Sequence 2 schedule) will allow all immunocompromised subjects entered on the Phase 1b portion of the study to receive NT-I7.
The vaccines, randomly assigned to be administered before NT-I7 therapy are administered six weeks before the administration of NT-I7 therapy.
The vaccines, randomly assigned to be administered after NT-I7 therapy are administered 3 weeks after NT-I7 injection.
- Being tested
- Recombinant human IL-7-hyFc (NT-I7), Vaccine sequence 1, Vaccine sequence 2
- Keywords
- Breast Cancer, Colorectal Cancer, Immune Insufficiency, Bladder Cancer, Immunocompromised Host
- Medical subject headings
- Breast Neoplasms, Urinary Bladder Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human IL-7-hyFc (NT-I7)Biological
NT-I7 administered at escalating doses of 720, and 960g/kg to determine OBD of NT-I7
Vaccine sequence 1Biological
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
Vaccine sequence 2Biological
Day 1 Immunization Pre-NT-I7: Hep A#1, Hep B#1 Day 64, Immunization Post-NT-I7:Td and Polio Day 106: no Vaccine 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2, Hep #3, PPSV23#1
| Study group | Role | What they receive |
|---|---|---|
| 1/ Arm 1 | Experimental | NT-I7 administered at 720 and 960g/kg to select the OBD of NT-I7 Receives: Biological: Recombinant human IL-7-hyFc (NT-I7) |
| 2/ Arm 2a | Active comparator | Administration of 4 vaccines according to Sequence 1 + NT-I7 administration at OBD to assess vaccine response Receives: Biological: Vaccine sequence 1 |
| 3/ Arm 2b | Active comparator | Administration of 4 vaccines according to Sequence 2 + NT-I7 administration at OBD to assess vaccine response Receives: Biological: Vaccine sequence 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety of NT-I7 in elderly patients after chemotherapy
List of adverse events and frequency
Measured: 28 days after treatment
Phase 1b: Evaluate and quantify if NT-I7 at optimal biological dose (OBD) has impacts on specific immune responses to vaccines
vaccine titers
Measured: day 42 and day 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start30 May 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: No subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- NeoImmuneTech
- Responsible party
- Sponsor
- Investigators
- Mustafa A Hyder, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054752
- Sponsor's protocol ID
- 190134
- Other IDs
- 19-C-0134
- Status last verified
- Nov 2023
- First submitted
- 10 Aug 2019
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04054752
- Acronym / sponsor ID
- 190134
- Keywords
- Breast Cancer, Colorectal Cancer, Immune Insufficiency, Bladder Cancer, Immunocompromised Host
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- NeoImmuneTech
- Study start
- 30 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
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.
Objective:
To see if NT-I7 can boost the immune system.
Eligibility:
Adults 60 and older who have recently finished chemotherapy for breast, colorectal, or bladder cancer.
Design:
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.
Detailed description
Background:
Interleukin-7 is a homeostatic cytokine with a critical role in lymphoid homeostasis through which it exerts its immune-restorative effects, particularly re-expansion of the na(SqrRoot) ve and memory T-cell subsets.
The clinical implications of the kinetics, nature and extent of immune reconstitution defects following standard or ablative chemotherapy in older adults with cancer (in particular the lack of reconstitution of large pools of na(SqrRoot) ve T-cell with broad repertoire diversity and of memory T-cells) are not well characterized.
As chemotherapy often induces only temporary complete or partial disease responses but no cure, candidates for novel immunotherapy strategies may be significantly impeded in their responses to active immunotherapy attempts, the therapeutic potential of which is becoming increasingly utilized.
Recombinant human IL-7 (rhIL-7) may play a role in immune reconstitution and immune enhancement in various circumstances of immune insufficiency in older individuals following chemotherapy or in the context of enhancing cancer immunotherapy or during immune senescence.
Elderly cancer survivors are vulnerable to vaccine-preventable diseases and are known to have poor anti-vaccine-specific immune responses. Effective prevention of communicable diseases is important for cancer survivorship.
This study will use NT-I7, a long acting IL-7 cytokine, composed of human IL-7 and a hybrid Fc (hyFc) region to extend half-life.
Objectives:
Phase 1: Select optimal biological dose (OBD) of NT-I7 in older subjects with breast, bladder, prostate or a gastrointestinal cancer following chemotherapy.
Phase 1b: Evaluate and quantify the functional impact of NT-I7 therapy on specific immune responses to selected vaccines in older subjects following chemotherapy.
Eligibility:
Adults greater than or equal to 60 year of age.
Diagnosis of non-metastatic breast, bladder or a gastrointestinal cancer following adjuvant / neo-adjuvant chemotherapy; or metastatic breast, gastrointestinal or prostate cancer after chemotherapy.
Completed a treatment with chemotherapy a minimum of 4 weeks and no more than 12 months prior to entry with no evidence of disease.
Reasonable expectation that no cancer-specific therapy will be given in the subsequent 6 months.
Design:
Subjects will be enrolled into this single center Phase 1/1b study following the specific therapy for their respective diseases.
In Phase 1 part of the study, two dose levels, 720 micro g/kg and 960 micro g/kg, will be compared. Six subjects will be enrolled in each dose level, and a single dose of NT-I7 will be delivered intramuscularly. The purpose of this part of the study is to select the OBD.
OBD is defined as the dose that yields the greatest rise in peak absolute total T-cell counts (peak value at any timepoint during the first 28 days post NT-I7 administration) with corresponding rise in na(SqrRoot) ve subsets of CD4+ and CD8+ T cells without accompanying substantial toxicities. Absolute increase is a delta between the baseline counts and the peak counts within each subject.
Once OBD is determined, the Phase 1b portion of this study will begin. Subjects will undergo immunizations with various antigens, randomized to be administered either before or after a single dose of NT-I7 at OBD. This inter-subject randomization of the order in which the immunizations are administered (according to the Sequence 1 or to the Sequence 2 schedule) will allow all immunocompromised subjects entered on the Phase 1b portion of the study to receive NT-I7.
The vaccines, randomly assigned to be administered before NT-I7 therapy are administered six weeks before the administration of NT-I7 therapy.
The vaccines, randomly assigned to be administered after NT-I7 therapy are administered 3 weeks after NT-I7 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1/ Arm 1 | Experimental | Biological: Recombinant human IL-7-hyFc (NT-I7)NT-I7 administered at 720 and 960g/kg to select the OBD of NT-I7 |
| 2/ Arm 2a | Active comparator | Biological: Vaccine sequence 1Administration of 4 vaccines according to Sequence 1 + NT-I7 administration at OBD to assess vaccine response |
| 3/ Arm 2b | Active comparator | Biological: Vaccine sequence 2Administration of 4 vaccines according to Sequence 2 + NT-I7 administration at OBD to assess vaccine response |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- 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 (http://www.nccn.org/professionals/physiciangls/fguidelines.asp)
- 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).
Key exclusion criteria (28 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human IL-7-hyFc (NT-I7)NT-I7 administered at escalating doses of 720, and 960g/kg to determine OBD of NT-I7 | Biological | 1/ Arm 1 |
| Vaccine sequence 1Day 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 | Biological | 2/ Arm 2a |
| Vaccine sequence 2Day 1 Immunization Pre-NT-I7: Hep A#1, Hep B#1 Day 64, Immunization Post-NT-I7:Td and Polio Day 106: no Vaccine 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2, Hep #3, PPSV23#1 | Biological | 3/ Arm 2b |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGAP.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa A Hyder, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human IL-7-hyFc (NT-I7), Vaccine sequence 1 and Vaccine sequence 2 in people with Breast Carcinoma and Colorectal Adenocarcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Safety of NT-I7 in elderly patients after chemotherapy (time frame: 28 days after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.