Genetically Engineered Lymphocytes for Melanoma
Trial Summary
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it does exclude patients taking steroids for disease control or pain management. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Genetically Engineered Lymphocytes for Melanoma?
What safety data exists for genetically engineered lymphocytes used in cancer treatment?
Genetically engineered T cell therapies, like CAR-T cells, have shown promise in treating cancer but come with safety concerns such as cytokine release syndrome (a severe immune reaction), neurotoxicity (nerve damage), and potential off-target effects (unintended impacts on healthy cells). Efforts are being made to improve safety, including integrating safety switches to manage these risks.16789
How does the treatment with genetically engineered lymphocytes for melanoma differ from other treatments?
This treatment is unique because it uses genetically engineered lymphocytes (a type of white blood cell) to target melanoma cells specifically, by modifying them to express highly reactive T-cell receptors (TCRs) that recognize melanoma antigens. This approach aims to enhance the body's immune response against cancer cells, which is different from traditional treatments that may not specifically target cancer cells in this way.12101112
What is the purpose of this trial?
This is a phase one trial to determine if genetically engineered lymphocytes can be safely delivered to patients with metastatic melanoma.
Research Team
Michael Nishimura, PhD
Principal Investigator
Loyola University Chicago
Eligibility Criteria
Adults with metastatic melanoma that can be measured, who are in good physical condition (ECOG PS 0 or 1), and have specific genetic markers (HLA-A2 positive, tyrosinase positive). They must not be pregnant, have had certain treatments recently, or suffer from severe systemic diseases. Prior immunotherapies are allowed except for Tyrosinase immunotherapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy Preparative Regimen
Participants undergo a non-myeloablative and lymphodepleting chemotherapy preparative regimen
Treatment
Participants receive genetically engineered lymphocytes with low dose IL-2
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dose 1
- Dose 2
- Dose 3
- Dose 4
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loyola University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator