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

  • Interventional
  • Recruiting
  • NCT04752358
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - Age ≥18 and <75 years

         - Diagnosis of Esophageal cancer or Esophagogastric junction cancer.

         - Previously received 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.

At a Glance

National Government IDNCT04752358

IRB#IRB21-0802

Lead SponsorAdaptimmune

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Recruiting