ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

Esophageal Cancer Clinical Trial

Official title:

A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04752358
• Other study ID #: ADP-0055-002
• Status: Terminated
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Esophagogastric Junction Cancer

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