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

Adaptimmune

Status and phase: Terminated; Phase 2

Conditions: Esophageal Cancer; Esophagogastric Junction Cancer

Treatments: Genetic: Autologous genetically modified ADP-A2M4CD8 cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT04752358

ADP-0055-002

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Autologous genetically modified ADP-A2M4CD8 cells

Experimental group

Treatment:

Genetic: Autologous genetically modified ADP-A2M4CD8 cells