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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04752358
Other study ID # ADP-0055-002
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 15, 2021
Est. completion date December 15, 2023

Study information

Verified date May 2024
Source Adaptimmune
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date December 15, 2023
Est. primary completion date June 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: - Age =18 and <75 years - Diagnosis of Esophageal cancer or Esophagogastric junction cancer. - Previously received treatment for advanced or metastatic disease. - Measurable disease according to RECIST v1.1. - HLA-A*02 positive - Tumor shows MAGE-A4 expression confirmed by central laboratory. - ECOG Performance Status of 0 or1. - Left ventricular ejection fraction (LVEF) =50%. Note: other protocol defined Inclusion criteria may apply Key exclusion criteria 1. Positive for any HLA-A*02 allele other than: one of the inclusion alleles 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study 3. Active autoimmune or immune mediated disease 4. Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases 5. Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease 6. Uncontrolled intercurrent illness 7. Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus 8. Pregnant or breastfeeding Note: other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Intervention

Genetic:
Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1

Locations

Country Name City State
Canada McGill University Health Centre Glen Site Montreal Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario
Spain Hospital Universitario 12 de Octubre Córdoba Madrid
Spain Hospital Clinico Universitario de Valencia Ibáñez Valencia
Spain Hospital Universitari Vall d'Hebron la Vall d'Hebron Barcelona
Spain Hospital Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario Madrid Sanchinarro (CIOCC) Madrid
Spain Clinica Universidad de Navarra Navarro
Spain Hospital Universitario Virgen del Rocio Sevilla
United States University of Chicago Medicine Chicago Illinois
United States City of Hope National Medical Center Duarte California
United States University Of Texas, MD Anderson Cancer Center Houston Texas
United States University Of Wisconsin Clinical Science Center Madison Wisconsin
United States Memorial Sloan Kettering Cancer Center New York New York
United States OU Health Stephenson Cancer Center Oklahoma City Oklahoma
United States Providence Cancer Institute Franz Clinic Portland Oregon
United States Washington University School of Medicine- Siteman Cancer Center Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Adaptimmune ICON plc

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Overall Response Rate (ORR) ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1 2.5 Years
Secondary 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 Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs) 2.5 years
Secondary Efficacy: Best overall response (BOR) Best Overall Response (BOR) is per RECIST V1.1. 2.5 Years
Secondary Time to response (TTR) 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. 2.5 years
Secondary Duration of Response (DoR) 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. 2.5 years
Secondary Progression Free Survival (PFS) PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death. 2.5 years
Secondary Overall Survival (OS) OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death. 15 years
Secondary Invitro diagnostic (IVD) assay for screening Development and validation of the MAGE-A4 antigen expression companion diagnostic assay 2.5 years
Secondary Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry 2.5 years
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