Using Modified White Blood Cells to Target G12D Mutated RAS in Cancer Patients with HLA-A*11:01

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03745326

Provider View

This study explores a new cancer treatment using genetically modified white blood cells to target specific tumor mutations. It aims to assess the safety and effectiveness of this approach in shrinking tumors.

Patient Parameters

Program Overview

This study is testing a new cancer treatment that involves taking a person's white blood cells, growing them in a lab, and genetically modifying them to help fight cancer. These modified cells are then returned to the patient. The treatment is designed to target tumors in people with specific types of cancer. The main goal is to see if these modified cells are safe and can help reduce the size of tumors. Participants will undergo various tests and procedures, including blood collection and hospital stays, to monitor the treatment's effects. Follow-up visits will continue for up to two years.

Description

This study is investigating a new cancer treatment that uses a special type of white blood cell. These cells are taken from the patient, grown in a lab, and genetically modified to recognize and attack cancer cells with a specific mutation called G12D in the RAS gene. The study is for patients who have this mutation and are HLA-A*11:01 positive.

The treatment involves several steps:

  • First, participants will have a procedure called leukapheresis to collect their white blood cells.
  • These cells are then modified in the lab to target the cancer cells.
  • Participants will receive chemotherapy to prepare their body for the modified cells.
  • The modified cells are then infused back into the patient through a catheter in the chest.
  • Patients may also receive additional medication to help the modified cells work better.

Participants will stay in the hospital for up to three weeks to recover and will need to take antibiotics for at least six months. They will have regular follow-up visits for two years to monitor their health and the treatment's effectiveness. Blood samples will be collected for several years to continue studying the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 72 years.
  • Must have cancer with the G12D mutation in the RAS gene.
  • Must be HLA-A*11:01 positive.
  • Cancer must be metastatic or cannot be removed by surgery.
  • Must have tried standard cancer treatments without success or have declined them.
  • Can have up to 3 small, stable brain metastases.
  • Must be in good general health (ECOG status 0 or 1).
  • Must agree to use birth control during and after the study.
  • Women must take a pregnancy test before starting treatment.
  • Must not have HIV, hepatitis B, or active hepatitis C.
  • Must have adequate blood counts and organ function.
  • Must be able to understand and sign a consent form.
  • Must agree to sign a durable power of attorney.
  • Must be enrolled in a related study protocol.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Currently using systemic steroids.
  • Have active infections or serious medical conditions.
  • Have a primary immune deficiency.
  • Have opportunistic infections.
  • Have severe allergies to study medications.
  • Have a history of heart problems or low heart function.
  • Have low lung function if prompted by medical history.
  • Are participating in other experimental treatments.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.