SUPPORT HOTLINE (888) 901-2226
Donate Now

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

Condition:

  • 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

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.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Locations

Facility Status Contact
Washington University - School of Medicine
Saint Louis, Missouri 63110
United States
Not yet recruiting Nic Perry
314-273-2831
nperry@wustl.edu
Roswell Park Cancer Institute
Buffalo, New York 14040
United States
Not yet recruiting Amy M Whitworth, RN, BSN
716-845-3089
amy.whitworth@roswellpark.org
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina 27710
United States
Not yet recruiting Shawna Savage, RN, BSN
919-668-1462
shawna.savage@duke.edu
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Not yet recruiting Elisabeth Giraud

Elisabeth.Giraud@fccc.edu
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Not yet recruiting Amanda B Mundy, BA
615-329-7400
amanda.mundy@scresearch.net
M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Danxia Ke
713-792-4384
dke@mdanderson.org
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Not yet recruiting Adrian G Sacher, MD
416-946-4501
TIP@uhn.ca