Study on Immunotherapy Combination: PD-L1 CAR-NK Cells, Pembrolizumab, and N-803 for Advanced Gastric or Head and Neck Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04847466

Provider View

This clinical trial is testing a new combination of immunotherapy treatments to see if they can help fight advanced gastric or head and neck cancer. The study involves using engineered immune cells, along with two other drugs, to target and destroy cancer cells.

Patient Parameters

Program Overview

This study is exploring a new cancer treatment that combines special immune cells called PD-L1 CAR-NK cells with two drugs, pembrolizumab and N-803, to treat advanced gastric or head and neck cancer. The goal is to see if this combination can effectively target and kill cancer cells that have resisted other treatments. Participants will receive these treatments over a period of up to two years, with regular follow-up visits to monitor their health and the treatment's effectiveness.

Description

This study involves a new approach to treating advanced gastric or head and neck cancer by using a combination of immunotherapy treatments. The treatment includes:

  • PD-L1 CAR-NK cells: These are specially engineered immune cells designed to recognize and attack cancer cells. They are given through an IV infusion once a week for six weeks, then every two weeks.
  • Pembrolizumab: This is an immunotherapy drug given through an IV every six weeks.
  • N-803: This is another drug that helps boost the immune system, given as an injection under the skin every four weeks.

Participants will receive these treatments for up to two years. They will have regular visits to the clinic every 1-2 weeks during treatment to monitor their health and the treatment's effects. After the treatment ends, participants will have follow-up contacts every two months for a year, then every six months, with regular tumor scans to check for any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced gastric or head and neck cancer that cannot be removed by surgery or has spread to other parts of the body.
  • Have already received standard cancer treatments, including chemotherapy and, if applicable, HER2-targeted therapy for gastric cancer.
  • Have a specific performance status score indicating they are in relatively good health.
  • Have adequate organ and blood cell function based on specific medical tests.
  • If they have brain metastases, these must be treated and stable.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for four months after the last dose of pembrolizumab.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Currently receiving other investigational treatments or anticancer therapies, except for palliative radiotherapy.
  • Using systemic steroids, except for low doses for specific conditions.
  • Have active autoimmune diseases, except for certain controlled conditions.
  • Have had severe immune-related side effects from similar treatments in the past.
  • Have active infections like HIV or hepatitis B.
  • Have uncontrolled health issues, such as heart problems or psychiatric conditions, that could interfere with the study.
  • Pregnant or breastfeeding women, due to potential risks to the baby.

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