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BRIEF TITLE: Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors

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

  • Org Study ID: ADP-0055-001
  • Secondary ID:
  • NCT ID: NCT04044859
  • NCT Alias:
  • Sponsor: Adaptimmune - Industry
  • Source: Adaptimmune

Brief Summary

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.

Overal Status Start Date Phase Study Type
Recruiting July 10, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - 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

Primary Outcome 1 - Time Frame: 2.5 years

Primary Outcome 2 - Measure: Evaluate safety of ADP-A2M4CD8 through measurement of Replication -competent Retrovirus in genetically engineered T-cells

Primary Outcome 2 - Time Frame: 15 years


  • 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


- 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No


Facility Status Contact
Washington University - School of Medicine
Saint Louis, Missouri 63110
United States
Not yet recruiting Nic Perry
Roswell Park Cancer Institute
Buffalo, New York 14040
United States
Not yet recruiting Amy M Whitworth, RN, BSN
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina 27710
United States
Not yet recruiting Shawna Savage, RN, BSN
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Not yet recruiting Elisabeth Giraud
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Not yet recruiting Amanda B Mundy, BA
M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Danxia Ke
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Not yet recruiting Adrian G Sacher, MD