Study on Using Genetically Modified T-Cells to Target Cancer Mutations in People with Metastatic Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03412877

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 specific mutations. 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 specific mutations, and then returning them to the patient's body. The main goal is to see if this gene transfer therapy can help shrink tumors in adults with metastatic cancer that has not responded to standard treatments. Participants will undergo several procedures, including blood collection, cell modification, and follow-up visits to monitor their progress and health.

Description

Researchers are testing a new therapy that uses a patient's own white blood cells, which are genetically modified to target specific mutations in cancer cells. This process involves studying the patient's tumor to identify mutations, then using a virus to transfer genes into the white blood cells, enabling them to attack the cancer. The modified cells are then returned to the patient to see if they can shrink the tumors.

The study includes several stages:

  1. Screening tests, including blood and urine tests, scans, and a physical exam.
  2. Collection of white blood cells through a process called leukapheresis.
  3. Modification of the cells in a lab over 4-6 weeks.
  4. Hospital stay for treatment, where an IV catheter is placed in the chest to administer drugs.
  5. Some patients will receive an additional drug, pembrolizumab, during their hospital stay and after the cell infusion.
  6. Infusion of the modified cells, followed by a drug to help the cells survive longer.
  7. Recovery in the hospital for 1-2 weeks, with ongoing tests and monitoring.
  8. Post-treatment care, including taking antibiotics and possibly antivirals for at least 6 months, with regular follow-up visits to monitor health and treatment effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 72 with metastatic solid cancer that can be measured and falls into specific categories, such as gastrointestinal, genitourinary, breast, ovarian, lung, endocrine tumors, or multiple myeloma with solid masses.
  • Cancer that has not responded to standard treatments.
  • Good overall health with normal lab values and no major medical illnesses.
  • Willingness to use birth control during and after the study.
  • Negative tests for HIV, hepatitis B, and hepatitis C.
  • Adequate blood cell counts and organ function.
  • Ability to understand and sign informed consent.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Use of systemic steroids or other immunosuppressive medications.
  • Active infections or major medical illnesses.
  • History of severe allergic reactions to study drugs.
  • Significant heart or lung issues.
  • Participation in other investigational drug studies.

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