Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer, Head and Neck Cancer, Melanoma, Non-small Cell Lung (NSCLC), Ovarian Cancer, Urothelial Cancer
Conditions
Keywords
Cell Therapy, T Cell Therapy, SPEAR T Cell, MAGE-A4, Immuno-oncology, Metastatic, Urothelial, Head and Neck, Gastric (stomach), Esophagogastric Junction (EGJ), Non-small Cell Lung (NSCLC), Esophageal Cancer, Ovarian Cancer, Endometrial Cancer, Melanoma
Brief summary
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.
Detailed description
Conditions: Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer
Interventions
GENETICAutologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks
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
Sponsors
USWM CT, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Key Inclusion criteria * Age ≥18 and ≤ 75 years * Subject is positive for at least 1 HLA-A\*02 inclusion allele * Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma * Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion. * Tumor shows MAGE-A4 expression as confirmed by central laboratory * ECOG Performance Status of 0 or 1. * Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/
Exclusion criteria
may apply * Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline. Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab | 2.5 years | Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose |
| To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab | Up to 15 years | Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | 2.5 years | 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 |
| Duration of stable disease (DoSD) | 2.5 years | 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 |
| Anti-tumor activity: Best overall response (BOR) | 2.5 years | BOR is per RECIST V1.1. |
| Overall Survival (OS) | 15 years | 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. |
| Anti-tumour activity: Overall Response Rate (ORR) | 2.5 years | ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1 |
| Progression Free Survival (PFS) | 2.5 years | 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 to response (TTR) | 2.5 years | 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. |
Countries
Canada, Spain, United States
Contacts
PRINCIPAL_INVESTIGATORDavid Hong, MD
M.D. Anderson Cancer Center
Outcome results
None listed