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Brief Title: Surpass: 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

INTRODUCTION

  • Org Study ID: ADP-0055-001
  • Secondary ID: N/A
  • NTC ID: NCT04044859
  • Sponsor: 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 urothelial, head and neck, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

  • Overall Status
    Recruiting
  • Start Date
    August 20, 2019
  • Phase
    Phase 1
  • Study Type
    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 - Timeframe: 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 - Timeframe: 15 years

CONDITION

  • Urothelial Carcinoma
  • Head and Neck
  • Gastric Cancer
  • Esophagogastric Junction Disorder
  • Nonsmall Cell Lung Cancer
  • Esophageal Cancer

ELIGIBILITY

Key Inclusion criteria

- Age ≥18 and ≤ 75 years

- Subject is positive for at least 1 HLA-A*02 inclusion allele

- Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal , esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck

- Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion.

- 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 any HLA-A*02 allele other than: one of the inclusion alleles

- 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
Note: other protocol defined Inclusion/Exclusion criteria may apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: David Hong, MD

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: David Hong, MD

Phone: 713-563-5844

Email: dshong@madanderson.org

LOCATION

Facility Status Contact
Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Contact
Jennifer Brown
314-273-7091 2813
JBROWN67@mgh.harvard.edu
Facility: Washington University - School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: Principal Investigator
Donald Lawrence, MD
916-668-1462
e.zhu@wustl.edu
Facility: Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Principal Investigator
Tanner M Johanns, MD
615-524-4284
Cynthia-Lowery@ouhsc.edu
Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
Shawna Savage
615-524-4118
Kara.Ryan@jefferson.edu
Facility: Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: Principal Investigator
Jeffrey M Clarke, MD
713-792-4384
Natisha.Muhammad@jefferson.edu
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Cynthia Lowery
416-634-7940
danielle.mccreary@sarahcannon.com
Facility: M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Principal Investigator
Adam Asch
+34 91 390 89 22
Montana.Simpson@SarahCannon.com
Facility: Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Kara Ryan
0034 91 550 48 00
DKe@mdanderson.org
Facility: Princess Margaret Cancer Centre
Toronto, Valencia 46010
Canada
Status: Recruiting Contact: Contact
Montana Simpson

leyreresano@unav.es
Facility: Hospital 12 De Octubre
Madrid, 28040
Spain
Status: Recruiting Contact: Principal Investigator
Melissa Johnson, MD

megana@unav.es
Facility: Clinica Universitaria de Navarra
Pio, 41013
Spain
Status: Recruiting Contact: Contact
Danxia Ke

iblasco@incliva.es
Facility: Hospital Clinico Universitario de Valencia
Ibanez,
Spain
Status: Recruiting Contact: Principal Investigator
David Hong, MD

sonia.perez@startmadrid.com
Facility: Start Madrid-FJD, Fundación Jimѐnez Díaz
Madrid,
Spain
Status: Recruiting Contact: Contact
Taylor Keaton

esther.ordonez@startmadrid.com
Facility: Centro Integral Oncologico, Clara Campal, HM CIOCC (START MADRID-CIOCC)
Madrid,
Spain
Status: Recruiting Contact: Principal Investigator
John A Charlson, MD

mariavazquezonco.huvr@gmail.com
Facility: Hospital Universitario Virgen del Rocio
Sevilla,
Spain
Status: Recruiting Contact: Contact
Genevieve Mendiola

oyarzabalma@hotmail.com