CD40L-augmented TIL for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CD40L-augmented TIL, a type of cell therapy, for individuals with advanced melanoma, a type of skin cancer. The researchers aim to determine if this treatment is safe and effective for patients whose cancer hasn't responded to standard therapies. Participants will have a tumor removed to prepare the treatment and will receive additional medications to aid the process. This trial suits those with advanced melanoma that has not improved with usual treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires that participants stop taking certain medications, such as systemic steroid therapy above a low dose, at least one week before starting the trial. If you are on immunosuppressive medications or high-dose steroids, you may need to taper off before participating.
Is there any evidence suggesting that CD40L-augmented TIL is likely to be safe for humans?
Research shows that Tumor-Infiltrating Lymphocyte (TIL) therapy has received FDA approval for treating melanoma, indicating its safety for this condition is well-understood. Studies are ongoing to test a new version called CD40L-augmented TIL, focusing on its safety.
Early results from other studies examine how well patients tolerate CD40L-augmented TIL, assessing how patients handle the treatment. Researchers closely monitor safety, especially after every four patients, to detect any harmful effects early.
While detailed safety information for CD40L-augmented TIL is still being collected, its similarity to the approved TIL therapy suggests it might be safe for treating melanoma. However, this treatment remains experimental, and further research is needed to confirm its safety.12345Why are researchers excited about this study treatment for melanoma?
Researchers are excited about CD40L-augmented TIL for melanoma because it introduces a novel approach to cancer treatment by enhancing the activity of tumor-infiltrating lymphocytes (TILs) with the CD40 ligand (CD40L). Most traditional treatments for melanoma, like immune checkpoint inhibitors and targeted therapies, focus on blocking cancer growth or boosting the immune response in a broader way. However, CD40L-augmented TIL specifically supercharges the immune cells already present in the tumor, potentially increasing their ability to attack cancer cells more effectively. This targeted enhancement could lead to better outcomes, especially for patients with rare melanoma subtypes, where existing treatments are limited.
What evidence suggests that CD40L-augmented TIL might be an effective treatment for melanoma?
Research has shown that a new treatment using enhanced immune cells, called CD40L-augmented tumor-infiltrating lymphocytes (TIL), may help treat advanced melanoma. CD40L activates immune cells like B-cells, potentially boosting the body's ability to fight cancer. This trial will evaluate CD40L-augmented TIL in different cohorts, including a Phase I safety trial, a Phase II efficacy trial, and a cohort for rare melanoma subtypes. Early results suggest these modified TILs could help melanoma patients who haven't responded to other treatments. While more clinical data is needed, this therapy offers a promising new way to address melanoma.12678
Who Is on the Research Team?
Lilit Karapetyan, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with advanced melanoma, specifically cutaneous acral and non-acral melanoma (26 people), as well as mucosal and uveal melanoma (10 people). Participants must have progressive disease after standard treatments. They will undergo tumor removal for TIL preparation and must be fit for lymphodepletion.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Tumor Excision
Patients undergo an excision of a readily accessible tumor for preparation of TIL
Lymphodepletion
Eligible patients undergo lymphodepletion with cyclophosphamide and fludarabine
Treatment
Patients receive a single dose of CD40L-augmented TIL followed by standard of care bolus dose interleukin-2
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for long-term outcomes such as overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- CD40L-augmented TIL
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor