Clinical trial NCT04752358: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
Official title: A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Esophageal Cancer
Esophagogastric Junction Cancer
Keywords: Cell Therapy
T Cell Therapy
SPEAR T Cell
MAGE-A4
Immuno-oncology
Metastatic
Esophagogastric Junction
Esophageal Cancer
Lead sponsor: Adaptimmune
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2021-02-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)
timeFrame: From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).
Secondary outcomes:
measure: Number and Percentage of Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
timeFrame: From start of lymphodepleting chemotherapy to end of Interventional Phase (up to 5 months)
measure: Time to Response (TTR) by IRAC
timeFrame: From T-cell infusion until first documented confirmed CR or PR
measure: Duration of Response (DoR) by IRAC
timeFrame: From initial date of first confirmed response (CR or PR) until PD or death
measure: Best Overall Response (BOR) by IRAC
timeFrame: From T-cell infusion until disease progression
measure: Progression Free Survival (PFS) by IRAC
timeFrame: From T-cell infusion until first documented PD, as assessed by IRAC, or death due to any cause, whichever occurs first
measure: Overall Response Rate (ORR) by Investigator Assessment
timeFrame: From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).
measure: Time to Response (TTR) by Investigator Assessment
timeFrame: From T-cell infusion until first documented confirmed CR or PR
measure: Duration of Response (DoR) by Investigator Assessment
timeFrame: From initial date of first confirmed response (CR or PR) until PD or death
measure: Best Overall Response (BOR) by Investigator Assessment
timeFrame: From T-cell infusion until disease progression (Up to 5 months)
measure: Progression Free Survival (PFS) by Investigator Assessment
timeFrame: From T-cell infusion until first documented PD, as assessed by Investigator, or death due to any cause, whichever occurs first (up to 5 months)
measure: Overall Survival (OS)
timeFrame: From T-cell infusion to death due to any reason (up to 7 months)
measure: Replication Competent Lentivirus
timeFrame: From T-cell infusion to end study (up to 7 months)
measure: Insertional Oncogenesis (IO)
timeFrame: From 1 year post T-cell infusion
measure: Peak Persistence
timeFrame: From T-cell infusion to end study (up to 7 months)
measure: Time to Peak Persistence
timeFrame: From T-cell infusion to end study (up to 7 months)
measure: Concordance of the MAGE A-4 Clinical Trial Assay and in Vitro Diagnostic (IVD) Kit.
timeFrame: Screening visit
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine- Siteman Cancer Center
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Houston
country: United States
facility: University Of Texas, MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University Of Wisconsin Clinical Science Center
state: Wisconsin
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre Glen Site
state: Quebec
city: la Vall d'Hebron
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid
city: Ibáñez
country: Spain
facility: Hospital Clinico Universitario de Valencia
state: Valencia
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro (CIOCC)
city: Navarro
country: Spain
facility: Clinica Universidad de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
References: