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

NCT04752358 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ADP-0055-002
• Study Type: interventional
• Target: 3
• Locations: 3 countries
• Sites: 17

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.

Conditions

Esophageal Cancer; Esophagogastric Junction Cancer

Keywords

Cell Therapy; T Cell Therapy; SPEAR T Cell; MAGE-A4; Immuno-oncology; Metastatic; Esophagogastric Junction; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)

  Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC

  From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).

Secondary Outcomes (16)

• Number and Percentage of Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)

  From start of lymphodepleting chemotherapy to end of Interventional Phase (up to 5 months)

• Time to Response (TTR) by IRAC

  From T-cell infusion until first documented confirmed CR or PR

• Duration of Response (DoR) by IRAC

  From initial date of first confirmed response (CR or PR) until PD or death

• Best Overall Response (BOR) by IRAC

  From T-cell infusion until disease progression

• Progression Free Survival (PFS) by IRAC

  From T-cell infusion until first documented PD, as assessed by IRAC, or death due to any cause, whichever occurs first

Study Arms (1)

Autologous genetically modified ADP-A2M4CD8 cells

EXPERIMENTAL

Genetic: Autologous genetically modified ADP-A2M4CD8 cells

Interventions

Autologous genetically modified ADP-A2M4CD8 cells GENETIC

Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1

Autologous genetically modified ADP-A2M4CD8 cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
• Active autoimmune or immune mediated disease
• Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
• Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
• Uncontrolled intercurrent illness
• Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
• Pregnant or breastfeeding

Sponsors & Collaborators

• Adaptimmune: lead
• ICON plc: collaborator

Study Sites (17)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Washington University School of Medicine- Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

Location

University Of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University Of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Hospital Universitari Vall d'Hebron

la Vall d'Hebron, Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Córdoba, Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Valencia

Ibáñez, Valencia, 46010, Spain

Location

Hospital Fundacion Jimenez Diaz

Madrid, 228040, Spain

Location

Hospital Universitario Madrid Sanchinarro (CIOCC)

Madrid, 28050, Spain

Location

Clinica Universidad de Navarra

Navarro, 31008, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials Management
• Organization: Adaptimmune

clinicaltrials@adaptimmune.com

+1 (215) 825-9260

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: September 15, 2021
• Primary Completion: June 9, 2023
• Study Completion: December 15, 2023
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-08

Locations

CA (2); US (8); ES (7)