Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors (VISTA)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2038
  • participants needed
    45
  • sponsor
    Baylor College of Medicine
Updated on 17 March 2022
platelet count
renal function
cancer
total bilirubin
absolute neutrophil count
measurable disease
carcinoma
growth factor
squamous cell carcinoma
lung cancer
neutrophil count
pancreatic adenocarcinoma
tumor cells
epidermal growth factor receptor
HER2
EGFR
primary tumor
gastric cancer
human epidermal growth factor
adenocarcinoma
erbb2
epidermal growth factor
bladder cancer
esophagus cancer
bladder tumor
kidney function test
lung carcinoma

Summary

This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer.

This study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cells called HER2 chimeric antigen receptor specific cytotoxic T lymphocytes (HER2 specific CAR T cells), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus that is designed to help the immune system including HER2 specific CAR T cell react to the tumor.

The study is looking at combining these two treatments together, because we think that the combination of treatments will work better than each treatment alone. We also hope to learn the best dose level of the treatments and whether or not it is safe to use them together.

In this study, CAdVEC will be injected into participants tumor at one tumor site which is most easiest to reach. Once it infects the cancer cells, activation of the immune response will occur so it can attack and kill cancer cells. (This approach may have limited effects on the other tumor sites that have not received the oncolytic virus injection, so, patients will also receive specific T cells following the intratumor CAdVEC injection.) These T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells.

Investigators want to see if these cells can survive in the blood and affect the tumor. Both CAdVEC and HER2-specific autologous CAR T are investigational products. They are not approved by the FDA.

Description

Treatment with CAdVEC:

On the first day of your treatment, participants will receive an injection of CAdVEC into your tumor.

A blood sample will be obtained from the participant before the CAdVEC intratumor injection . Depending on the location of the tumor, different techniques can be used for the injection into your tumor. The most common route of injection is ultrasound-guided percutaneous (needle puncture in the skin) injection, but endoscopic (using a lighted, flexible instrument called an endoscope) ultrasound-guidance will be used for some patients as appropriate. Prior to percutaneous injection, participants may receive an anti-anxiety medicine to calm them down, to relieve muscle spasms, and provide sedation. If the participants tumor is injected during an endoscopic procedure, the procedure may be done under sedation.

Treatment with HER2- specific autologous T Cells:

Earlier the participant gave blood for us to make HER2 targeting cytotoxic T-lymphocytes (HER2- specific autologous T Cells). These cells are grown in the lab and frozen for participants. Invesitgators made the cells by combining dendritic cells (DCs) or monocytes with the T cells in the presence of produced mixtures of adenoviral proteins. Investigators then put a new gene in to those T cells to make them specifically attract to and kill HER2 positive tumors. As the T cells grow, they are cultured by adding adenoviral proteins for stimulation and expansion. Investigators call those T cells: HER2- targeting T cells (HER2- specific autologous T Cells).

This study looks at different doses of HER2- specific autologous T Cells. The decision about the dose participants receive is determined when enrolled on the study.

Seven dose levels will be evaluated. Cohorts of size 3 will be enrolled at each dose level until 9 evaluable patients have been studied at a single dose. Each patient will receive an intratumoral injection of CAdVEC alone or combined with an injection of HER2.CAR T cells.

CAdVEC intratumoral injection will be given as a single injection to a single appropriate tumor site by direct, endoscopic, or image-guided injection on Day 1. The injection site will be chosen based on a combination of criteria, including accessibility and safety of injection site; tumor size; and anticipated tumor viability (e.g. avoid necrotic or cystic injection sites). HER2.CAR T cells will be given intravenously on day 4 after CAdVEC injection, with a 3 day window (until day 7).

Before receiving the T cell infusion, participants may be given Benadryl (diphenhydramine) and Tylenol (acetaminophen). Tylenol and Benadryl are given to prevent a possible allergic reaction to the T cell administration.

Standard medical tests before treatment:

Before being treated, participants will receive a series of standard medical tests and procedures as well as research blood draws.

Standard Medical tests during and after treatment:

During treatment, participants will receive standard medical tests and procedures as well as research blood draws.

Study specific evaluations:

Investigators will follow participants closely after treatment for any side effects for at least 2 years after the last infusion.

To learn more about the way the T cells are working in the body, an extra blood sample will be taken before the CAdVEC injection, before the CAR T cell infusion, and at week 1, 2, 4 , 6, months 3, 6, 9 and 12 after CAR T cell infusion. Thereafter every 6 months up to 5 years and then yearly for 15 years. Investigators will use this blood to see how long the T cells last and to look at the immune response to the cancer. Investigators may also ask to get a tumor tissue biopsy at week 12 if necessary. Buccal swabs (cheek scraping) and urine will be collected before CAdVEC injection, Days 2, 4 (or the day of CAR T-cell infusion), weeks 1 and 2 after CAR T cell infusion.

Details
Condition Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Salivary Gland, Lung Cancer, Breast Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma, Solid Tumor
Treatment CAdVEC
Clinical Study IdentifierNCT03740256
SponsorBaylor College of Medicine
Last Modified on17 March 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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