Tumor-infiltrating lymphocyte (TIL) therapy entails extracting T cells from a patient's tumor, stimulating and multiplying them in a laboratory setting, and then reintroducing them into the patient to target and eradicate cancer cells.

Dr. Kedar Kirtane, medical oncologist in the Head and Neck Oncology Program at Moffitt Cancer Center, is the principal investigator for a Phase IB clinical trial focusing on Squamous Cell Cancer Tumor-Infiltrating Lymphocytes (TIL).

The primary objective of this trial is to assess the safety and tolerability of NMA-LD chemotherapy, TBio-4101, aldesleukin (IL-2), and pembrolizumab in individuals with HNSCC who have experienced initial progression on pembrolizumab or pembrolizumab/platinum therapy. Secondary objective involves determining the overall response rate (ORR) of TBio-4101 in combination with pembrolizumab, as well as the durable response rate (DRR), duration of response (DoR), and disease control rate (DCR). Additionally, the feasibility of TBio-4101 is assessed.

Exploratory objectives include:

• Characterizing the pharmacodynamics and evaluating biomarkers of TBio-4101 and pembrolizumab from tumor tissue and peripheral blood
• Assessing time to progression (TTP),progression-free survival (PFS), and overall survival (OS), exploring the antitumor activity of pembrolizumab combined with TBio-4101 using immune-related response criteria (irRC)
• Examining the potential significance of T cell phenotype such as TCR clonality and diversity and tumor antigen reactivity of TBio-4101 in correlation with clinical outcomes
• Evaluating TBio-4101 engraftment, persistence, activation, phenotype, transcriptome profile, and tumor infiltration
• Correlating these findings with clinical outcomes

Furthermore, a comparison is made between baseline and on-treatment determinants in the tumor through pathology and genomic analysis of pre- and on-treatment biopsies in relation with clinical response.

If you’d like to refer a patient to Moffitt for this clinical trial, complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.