Vaccine Response With NT-I7

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. 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.

Conditions

• Breast Carcinoma
• Colorectal Adenocarcinoma
• Bladder Carcinoma

Interventions

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

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

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 Day 106: no Vaccine 6 Month Post NT-I7 Vaccines (Optional): Polio, Hep A#2, Hep #3, PPSV23#1

Sponsors & Collaborators

• NeoImmuneTech

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Mustafa A Hyder, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-30

Primary Completion

2023-11-01

Completion

2023-11-01

FDA Drug

Yes

Countries

• United States

Study Locations