Study on Using Genetically Modified White Blood Cells to Treat Cancers with a Specific KRAS Mutation in HLA-A*11:01 Patients

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03190941

Provider View

This clinical trial is testing a new treatment that uses a patient's own white blood cells, which are modified in the lab to target and attack cancer cells with a specific KRAS mutation. The study aims to determine if this approach is safe and effective in reducing tumors in adults with certain advanced cancers.

Patient Parameters

Program Overview

This study is exploring a novel cancer treatment that involves taking a patient's white blood cells, genetically modifying them in the laboratory to recognize and attack cancer cells with a specific KRAS G12V mutation, and then returning them to the patient's body. The main goals are to assess the safety of this treatment and to see if it can help shrink tumors in adults aged 18 to 72 who have advanced cancers that express the target molecule. Participants will undergo several procedures, including blood collection, chemotherapy, infusion of the modified cells, and follow-up visits over two years to monitor their progress and health.

Description

Researchers have developed a new therapy that targets cancers with a specific mutation in the KRAS gene, known as G12V. This mutation is present in various cancers and makes them harder to treat. The therapy involves modifying a patient's own white blood cells to recognize and attack these cancer cells. The modified cells are created by introducing a special receptor that specifically binds to the mutated KRAS. In laboratory tests, these modified cells have successfully destroyed cancer cells with the KRAS G12V mutation.

The study is divided into two phases: Phase I focuses on ensuring the treatment is safe, while Phase II evaluates its effectiveness in shrinking tumors. Up to 110 patients may participate, with some receiving treatment for pancreatic cancer and others for different types of cancer. The treatment process includes collecting white blood cells, modifying them in the lab, administering chemotherapy to prepare the body, infusing the modified cells, and providing supportive medications to help the cells work effectively.

Participants will stay in the hospital for 1-2 weeks after the infusion and will take antibiotics for at least six months to prevent infections. Regular follow-up visits will monitor the patients' health and the treatment's impact over two years.

Eligibility Criteria

Inclusion Criteria

  • Have a measurable, advanced cancer that cannot be removed by surgery or has spread to other parts of the body, and has the KRAS G12V mutation.
  • Be between 18 and 72 years old.
  • Have a specific genetic marker called HLA-A*11:01.
  • Have cancer that has not responded to standard treatments or has returned after treatment.
  • Have no more than three small brain tumors that are not causing symptoms and have been stable after treatment.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Agree to use birth control during the study and for 12 months after treatment for women, and for four months for men.
  • Women must not be pregnant and must undergo a pregnancy test before starting treatment.
  • Test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control with appropriate treatments.
  • Have adequate blood cell counts, including white blood cells, platelets, and hemoglobin levels.
  • Have good liver and kidney function as indicated by specific blood tests.
  • Have completed any previous cancer treatments and recovered from any side effects.
  • Understand the study and agree to sign informed consent.
  • Willing to sign a durable power of attorney.
  • Be enrolled in a related study protocol (03C0277).

Exclusion Criteria

  • Have had large volume radiation to the lungs.
  • Women who are pregnant or breastfeeding due to potential risks to the baby.
  • Currently taking systemic steroids or other immunosuppressive medications.
  • Have active infections that require treatment or other serious medical conditions.
  • Have primary immunodeficiency disorders.
  • Have a history of severe allergic reactions to any of the study drugs.
  • Have recently had heart procedures, heart attacks, or unstable chest pain.
  • Have significant lung problems, such as very low lung function.
  • Currently participating in another clinical trial or taking investigational drugs.

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