This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.
Conditions: Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks
Name of Institution: Orlando Health Cancer Institute
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University - School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
...and 7 more locations
To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab
Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose
Time frame: 2.5 years
To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab
Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.
Time frame: Up to 15 years
Anti-tumour activity: Overall Response Rate (ORR)
ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
Time frame: 2.5 years
Anti-tumor activity: Best overall response (BOR)
BOR is per RECIST V1.1.
Time frame: 2.5 years
Time to response (TTR)
For patients who are observed to respond to ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab, the time taken to achieve a partial response or complete response (TTR) is assessed.
Time frame: 2.5 years
Duration of Response (DOR)
For patients who are observed to respond to ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab, the DOR is the date of first response (including confirmation) up until disease progression per RECIST v 1.1 or death
Time frame: 2.5 years
Duration of stable disease (DoSD)
For patients who are observed to have stable disease by RECIST v 1.1, the duration of period of stable disease until disease progression or death
Time frame: 2.5 years
Progression Free Survival (PFS)
PFS is assessed from date of infusion of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab up until the date of disease progression per RECIST v1.1 or death.
Time frame: 2.5 years
Overall Survival (OS)
OS is assessed from date of infusion of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab up until the date of patient death.
Time frame: 15 years
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