NCT04054752

Vaccine Response With NT-I7

Withdrawn Phase 1 Last updated 2 November 2023

What this trial tests

Phase 1 trial testing Recombinant human IL-7-hyFc (NT-I7) in Breast Carcinoma. Withdrawn.

Timeline

30 May 2023

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	30 May 2023
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Recombinant human IL-7-hyFc (NT-I7) — full drug profile →
• Vaccine sequence 1 — full drug profile →
• Vaccine sequence 2 — full drug profile →

Conditions studied

• Breast Carcinoma — all drugs for Breast Carcinoma →
• Colorectal Adenocarcinoma — all drugs for Colorectal Adenocarcinoma →
• Bladder Carcinoma — all drugs for Bladder Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

60 and older, any sex, with Breast Carcinoma or Colorectal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of IL-7 and IL-7R in Cancer Pathophysiology and Immunotherapy.
   Wang C, Kong L, Kim S, Lee S, et al · · 2022 · cited 78× · PMID 36142322 · DOI 10.3390/ijms231810412
2. The Role of Inflammatory Cytokines in the Pathogenesis of Colorectal Carcinoma-Recent Findings and Review.
   Borowczak J, Szczerbowski K, Maniewski M, Kowalewski A, et al · · 2022 · cited 49× · PMID 35884974 · DOI 10.3390/biomedicines10071670
3. Advances in IL-7 Research on Tumour Therapy.
   Fu C, Zhang X, Zhang X, Wang D, et al · · 2024 · cited 17× · PMID 38675377 · DOI 10.3390/ph17040415