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Trial record 1 of 1 for:    NCT04752358
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ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04752358
Recruitment Status : Active, not recruiting
First Posted : February 12, 2021
Last Update Posted : April 18, 2023
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Adaptimmune

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Esophagogastric Junction Cancer Genetic: Autologous genetically modified ADP-A2M4CD8 cells Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous genetically modified ADP-A2M4CD8 cells Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy: Overall Response Rate (ORR) [ Time Frame: 2.5 Years ]
    ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1


Secondary Outcome Measures :
  1. 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 [ Time Frame: 2.5 years ]
    Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)

  2. Efficacy: Best overall response (BOR) [ Time Frame: 2.5 Years ]
    Best Overall Response (BOR) is per RECIST V1.1.

  3. Time to response (TTR) [ Time Frame: 2.5 years ]
    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.

  4. Duration of Response (DoR) [ Time Frame: 2.5 years ]
    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.

  5. Progression Free Survival (PFS) [ Time Frame: 2.5 years ]
    PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.

  6. Overall Survival (OS) [ Time Frame: 15 years ]
    OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.

  7. Invitro diagnostic (IVD) assay for screening [ Time Frame: 2.5 years ]
    Development and validation of the MAGE-A4 antigen expression companion diagnostic assay

  8. Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]
    Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752358


Locations
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Sponsors and Collaborators
Adaptimmune
ICON plc
More Information
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Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT04752358    
Other Study ID Numbers: ADP-0055-002
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaptimmune:
Cell Therapy
T Cell Therapy
SPEAR T Cell
MAGE-A4
 Immuno-oncology
Metastatic
Esophagogastric Junction
Esophageal Cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases