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Cancer Vaccine

Recombinant human IL-7-hyFc (NT-I7) for Colorectal Cancer

Phase 1
Waitlist Available
Led By Ronald E Gress, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Stage II or III gastrointestinal cancer following appropriate surgery and adjuvant chemotherapy or following appropriate neoadjuvant chemoradiation/surgery and adjuvant chemotherapy.
Effects of NT-I7 on the developing human fetus are unknown. For these reasons the following measures apply:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 42 and day 106
Awards & highlights

Study Summary

This trial is testing a new drug, NT-I7, to see if it can help boost the immune system in older cancer survivors. Eligible participants must be 60 or older, and have recently finished chemotherapy for breast, colorectal, or bladder cancer.

Eligible Conditions
  • Colorectal Cancer
  • Bladder Cancer
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have advanced stage gastrointestinal cancer that has been treated with surgery and chemotherapy or chemoradiation.
Select...
We don't know if NT-I7 is safe for unborn babies. So, if you are pregnant, you cannot participate in the study.
Select...
You have had breast cancer that was treated with chemotherapy, surgery, and/or radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 42 and day 106
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 42 and day 106 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Safety of NT-I7 in elderly patients after chemotherapy
Phase 1b: Evaluate and quantify if NT-I7 at optimal biological dose (OBD) has impacts on specific immune responses to vaccines

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 1/ Arm 1Experimental Treatment1 Intervention
NT-I7 administered at 720 and 960g/kg to select the OBD of NT-I7
Group II: 2/ Arm 2aActive Control1 Intervention
Administration of 4 vaccines according to Sequence 1 + NT-I7 administration at OBD to assess vaccine response
Group III: 3/ Arm 2bActive Control1 Intervention
Administration of 4 vaccines according to Sequence 2 + NT-I7 administration at OBD to assess vaccine response

Find a Location

Who is running the clinical trial?

NeoImmuneTechIndustry Sponsor
10 Previous Clinical Trials
507 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
NeoImmuneTech, Inc.UNKNOWN

Media Library

NT-I7 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04054752 — Phase 1
Colorectal Cancer Research Study Groups: 1/ Arm 1, 2/ Arm 2a, 3/ Arm 2b
Colorectal Cancer Clinical Trial 2023: NT-I7 Highlights & Side Effects. Trial Name: NCT04054752 — Phase 1
NT-I7 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054752 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total capacity of subjects being recruited for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the recruitment process for this medical trial is ongoing and began on December 1st 2022. The study was recently updated on November 25th of the same year; it seeks 68 volunteers across a single site."

Answered by AI

Is recruitment for this trial ongoing?

"Verified. The information on clinicaltrials.gov states that this trial is actively searching for appropriate candidates to participate in it. It was initially made available on December 1st 2022 and has been updated recently, the 25th of November 2022. 68 volunteers need to be recruited from one single medical centre."

Answered by AI

Has this trial been conducted previously or is it the inaugural exploration of its kind?

"Since its initial study in 2018, led by NeoImmuneTech and involving 12 participants, Recombinant human IL-7-hyFc (NT-I7) has been granted Phase 1 drug approval. Currently there are 11 ongoing trials for this compound spread across 39 cities within 4 countries."

Answered by AI

Has the FDA granted permission for Recombinant human IL-7-hyFc (NT-I7) to be used in clinical practice?

"Based on our team's assessment, Recombinant human IL-7-hyFc (NT-I7) is deemed to have a safety rating of 1 given that it is still in its first trial phase with limited evidence supporting both efficacy and security."

Answered by AI
~0 spots leftby Mar 2025