Description:
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 tumor antigen status and
whose urothelial, head and neck, gastric (stomach), esophagogastric junction (EGJ), non-small
cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.
Title
- Brief Title: Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors
- Official Title: A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors
Clinical Trial IDs
- ORG STUDY ID:
ADP-0055-001
- NCT ID:
NCT04044859
Conditions
- Urothelial Carcinoma
- Head and Neck
- Gastric Cancer
- Esophagogastric Junction Disorder
- Nonsmall Cell Lung Cancer
- Esophageal Cancer
Purpose
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 tumor antigen status and
whose urothelial, head and neck, gastric (stomach), esophagogastric junction (EGJ), non-small
cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Autologous genetically modified ADP-A2M4CD8 cells | Experimental | | |
Eligibility 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
- 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
Key exclusion criteria
- Positive for any HLA-A*02 allele other than: one of the inclusion alleles
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to fludarabine, cyclophosphamide or other agents used in the study
- Active autoimmune or immune mediated disease
- Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
- Other prior malignancy that is not considered by the Investigator to be in complete
remission. Clinically significant cardiovascular disease
- Uncontrolled intercurrent illness
- Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C
virus, or human T cell leukemia virus
- Pregnant or breastfeeding
Note: other protocol defined Inclusion/Exclusion criteria may apply.
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs) |
Secondary Outcome Measures
| Measure: | Anti-tumour activity: Overall Response Rate (ORR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1 |
| Measure: | Anti-tumor activity: Best overall response (BOR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | BOR is per RECIST V1.1. |
| Measure: | Time to response (TTR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | For patients who are observed to respond to ADP-A2M4CD8, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed |
| Measure: | Duration of Response (DOR) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | For patients who are observed to respond to ADP-A2M4CD8, the DOR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death. |
| Measure: | Duration of stable disease (DoSD) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | 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 |
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | 2.5 years |
| Safety Issue: | |
| Description: | PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death. |
| Measure: | Overall Survival (OS) |
| Time Frame: | 15 years |
| Safety Issue: | |
| Description: | OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Adaptimmune |
Trial 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
Last Updated
May 13, 2021
