This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A\*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Single infusion of autologous genetically modified ADP-A2M4 Dose: 1.0 x109 to 10x109 transduced cells by a single intravenous infusion Repeat doses of pembrolizumab every 3 weeks. Dose: 200mg
Mayo Clinic Phoenix
Phoenix, Arizona, United States
University of California San Diego
San Diego, California, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Karmanos Cancer Insitute
Detroit, Michigan, United States
Efficacy: Overall Response Rate (ORR)
ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1
Time frame: 2.5 years
Best overall response (BOR)
BOR defined as the best response recorded from the date of T cell infusion until disease progression.
Time frame: 2.5 years
Time to response (TTR)
TTR defined as the duration between T cell infusion and the initial date of the confirmed response.
Time frame: 2.5 years
Duration of response (DoR)
DoR defined as the duration from the initial date of the confirmed response to the date of PD (or death).
Time frame: 2.5 years
Duration of stable disease (DoSD)
DoSD defined as the duration from the date of T cell infusion to the date of PD (or death).
Time frame: 2.5 years
Progression- free survival (PFS)
PFS defined as the interval between the date T cell infusion and the earliest date of disease progression based on RECIST v1.1 or death due to any cause.
Time frame: 2.5 years
Overall survival (OS)
OS defined the duration between T cell infusion and death due to any cause.
Time frame: 2.5 years
To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining incidence of Adverse events (AEs) including serious adverse events (SAEs)
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Providence Cancer Institute Franz Head and Neck Clinic
Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
Determination of incidence, severity and duration of adverse events through assessment of adverse events including SAEs. Adverse events will be collected and graded as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 2.5 years
To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining the incidence, severity and duration of the AEs of special interest
Adverse events of special interest will be listed along with duration and toxicity grade.
Time frame: 2.5 years
To evaluate safety of ADP-A2M4 with pembrolizumab through measurement of Replication-competent Lentivirus in genetically engineered T-cells
Evaluation of RCL using PCR-based assay in peripheral blood.
Time frame: 15 years