Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous genetically modified ADP-A2M4CD8 cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks | Genetic | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumour activity: Overall Response Rate (ORR) | ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1 | 2.5 years |
| Anti-tumor activity: Best overall response (BOR) |
Not provided
Key exclusion criteria
Note: other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Hong, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Name of Institution: Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States | ||
| Massachusetts General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
|
BOR is per RECIST V1.1.
| 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. | 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 | 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 | 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. | 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. | 15 years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Washington University - School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center, Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Hospital Universitario 12 De Octubre | Madrid | Avenida de Cordoba S/n | 28041 | Spain |
| Clinica Universitaria de Navarra | Pío | Pamplona | 31008 | Spain |
| Hospital Clinico de Valencia | Ibanez | Valencia | 46010 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro CIOCC | Madrid | 28050 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008545 | Melanoma |
| D010051 | Ovarian Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided