Adoptive T Cell Therapy for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that patients taking steroids for disease control or pain management are excluded. It also requires a waiting period after certain treatments, like a 6-week gap after anti-CTLA-4 treatment and a 4-week gap after anti-PD-1 or anti-PD-L1 treatment.
Is adoptive T cell therapy for melanoma safe?
Initial studies show that genetically engineered T cells can cause tumor regression, but there are safety concerns like 'on-target, off-organ' toxicity, which means the treatment might affect healthy tissues. Efforts are being made to improve safety by carefully selecting target antigens and enhancing T cell receptor design.12345
What makes the treatment Autologous TIL 1383I TCR Gene Modified T Cells unique for melanoma?
This treatment is unique because it involves modifying a patient's own T cells to specifically target melanoma cells by introducing a gene for a T-cell receptor (TCR) that recognizes a melanoma-associated antigen. This approach aims to enhance the body's immune response against the cancer, offering a personalized and potentially more effective treatment option compared to traditional therapies.34678
What data supports the effectiveness of the treatment Autologous TIL 1383I TCR Gene Modified T Cells for melanoma?
Research shows that adoptive cell therapy using tumor-infiltrating lymphocytes (TILs) has led to significant responses in about 50% of patients with metastatic melanoma. Additionally, T cells modified with specific T-cell receptors (TCRs) have shown promise in targeting melanoma cells, suggesting potential effectiveness of this treatment.346910
Who Is on the Research Team?
Michael Nishimura, PhD
Principal Investigator
Loyola University
Are You a Good Fit for This Trial?
Adults with advanced melanoma that can be measured, who are in good physical condition (ECOG PS of 0 or 1), and have tried certain treatments without success. They must not be pregnant, vulnerable individuals, or have severe infections or other health conditions that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive escalating doses of TIL 1383I TCR transduced T cells to determine the maximum tolerated dose
Follow-up
Participants are monitored clinically and immunologically for safety and effectiveness after T cell infusion
What Are the Treatments Tested in This Trial?
Interventions
- Autologous TIL 1383I TCR Gene Modified T Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loyola University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator