Clinical Trials /

Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

NCT04044859

Description:

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), melanoma, urothelial, head and neck, ovarian, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
  • Esophagogastric Carcinoma
  • Gastric Carcinoma
  • Head and Neck Carcinoma
  • Malignant Ovarian Neoplasm
  • Melanoma
  • Myxoid Liposarcoma
  • Non-Small Cell Lung Carcinoma
  • Round Cell Liposarcoma
  • Synovial Sarcoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors
  • Official Title: A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors

Clinical Trial IDs

  • ORG STUDY ID: ADP-0055-001
  • NCT ID: NCT04044859

Conditions

  • Synovial Sarcoma
  • Myxoid/Round Cell Liposarcoma (MRCLS)
  • Melanoma
  • Urothelial Carcinoma
  • Head and Neck
  • Ovarian
  • Gastric Cancer
  • Esophagogastric Junction Disorder
  • Nonsmall Cell Lung Cancer
  • Esophageal Cancer

Purpose

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), melanoma, urothelial, head and neck, ovarian, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

Trial Arms

NameTypeDescriptionInterventions
Autologous genetically modified ADP-A2M4CD8 cellsExperimental

    Eligibility Criteria

            -  Key Inclusion criteria
    
              -  Age ≥18 and ≤ 75 years
    
              -  Histologically or cytogenetically confirmed diagnosis of urothelial cancer, melanoma,
                 ovarian cancer, esophageal , esophagogastric junction (EGJ) cancer, gastric cancer,
                 non-small cell lung carcinoma (NSCLC), head and neck, synovial sarcoma or myxoid/round
                 cell liposarcoma (MRCLS)
    
              -  Measurable disease according to RECIST v1.1 prior to leukapheresis and
                 lymphodepletionHLA-A*02 positive.
    
              -  Tumor shows MAGE-A4 expression as confirmed by central laboratory
    
              -  ECOG Performance Status of 0 or 1.
    
              -  Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of
                 normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion
                 criteria may apply
    
            Key exclusion criteria
    
              -  Positive for HLA-A*02:05 or HLA-A*02 allele other than A*02:07 or A*02 null allele
    
              -  History of allergic reactions attributed to compounds of similar chemical or biologic
                 composition to fludarabine, cyclophosphamide or other agents used in the study
    
              -  History of 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
    
            Note: other protocol defined Inclusion/Exclusion criteria may apply.
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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
    Safety Issue:
    Description:Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)

    Secondary Outcome Measures

    Measure:Anti-tumour activity: Overall Response Rate (ORR)
    Time Frame:2.5 years
    Safety Issue:
    Description:ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
    Measure:Anti-tumor activity: Best overall response (BOR)
    Time Frame:2.5 years
    Safety Issue:
    Description:BOR is per RECIST V1.1.
    Measure:Time to response (TTR)
    Time Frame:2.5 years
    Safety Issue:
    Description: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
    Measure:Duration of Response (DOR)
    Time Frame:2.5 years
    Safety Issue:
    Description: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.
    Measure:Duration of stable disease (DoSD)
    Time Frame:2.5 years
    Safety Issue:
    Description:For patients who are observed to have stable disease by RECIST v 1.1, the duration of period of stable disease until disease progression or death
    Measure:Progression Free Survival (PFS)
    Time Frame:2.5 years
    Safety Issue:
    Description:PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.
    Measure:Overall Survival (OS)
    Time Frame:15 years
    Safety Issue:
    Description:OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Adaptimmune

    Trial Keywords

    • Cell Therapy
    • T Cell Therapy
    • SPEAR T Cell
    • MAGE-A4
    • Immuno-oncology
    • Metastatic
    • Synovial Sarcoma
    • Myxoid/Round Cell Liposarcoma (MRCLS)
    • Melanoma
    • Urothelial
    • Head and Neck
    • Ovarian
    • Gastric (stomach)
    • Esophagogastric Junction (EGJ)
    • Non-small Cell Lung (NSCLC)
    • Esophageal Cancer

    Last Updated