ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

Study 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 MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

  • - 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 or ovarian cancer, endometrial cancer, melanoma.
  • - 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.
  • - Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04044859
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Adaptimmune
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Hong, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer, Head and Neck Cancer, Melanoma, Ovarian Cancer, Non-small Cell Lung (NSCLC), Urothelial Cancer
Additional Details

Conditions: Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer

Arms & Interventions

Arms

Experimental: Autologous genetically modified ADP-A2M4CD8 cells

Interventions

Genetic: - Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks

Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orlando, Florida

Status

Recruiting

Address

Name of Institution: Orlando Health Cancer Institute

Orlando, Florida, 32806

Site Contact

Sajeve S Thomas, MD

sajeve.thomas@orlandohealth.com

321-841-6780

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Donald P Lawrence

dplawrence@mgh.harvard.edu

617-643-3614

Saint Louis, Missouri

Status

Recruiting

Address

Washington University - School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Rebecca Munsch

munschr@wustl.edu

314-273-2726

Roswell Park Cancer Institute, Buffalo, New York

Status

Withdrawn

Address

Roswell Park Cancer Institute

Buffalo, New York, 14040

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

David Aggen, MD

cart@mskcc.org

646-608-2091

Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center, Duke Cancer Institute

Durham, North Carolina, 27710

Site Contact

Alex Guess

m.alex.guess@duke.edu

919-668-6406

OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma

Status

Recruiting

Address

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Site Contact

Silas Day

Silas-Day@ouhsc.edu

405-271-8001 #48748

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Withdrawn

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Sarah Cannon Research Institute, Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Site Contact

Nurse Navigators

dshong@madanderson.org

615-329-7274

M.D. Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M.D. Anderson Cancer Center

Houston, Texas, 77030

Site Contact

David Hong, MD

dshong@mdanderson.org

713-563-1930

Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Jessica Neumann

jneumann@mcw.edu

414-805-8342

International Sites

Cliniques Universitaires Saint-Luc, Bruxelles, Belgium

Status

Withdrawn

Address

Cliniques Universitaires Saint-Luc

Bruxelles, ,

University Hospital Antwerp, Edegem, Belgium

Status

Withdrawn

Address

University Hospital Antwerp

Edegem, ,

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Withdrawn

Address

Universitair Ziekenhuis Gent

Gent, ,

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Site Contact

Genevieve Mendiola

genevieve.mendiola@uhn.ca

416-634-7940

Hospital Universitario 12 De Octubre, Madrid, Avenida De Cordoba S/n, Spain

Status

Recruiting

Address

Hospital Universitario 12 De Octubre

Madrid, Avenida De Cordoba S/n, 28041

Clinica Universitaria de Navarra, Pio, Pamplona, Spain

Status

Recruiting

Address

Clinica Universitaria de Navarra

Pio, Pamplona, 31008

Site Contact

Mariano Ponz-Sarvisé, MD PhD

mponz@unav.es

+34 948 25 54 00

Hospital Clinico de Valencia, Ibanez, Valencia, Spain

Status

Recruiting

Address

Hospital Clinico de Valencia

Ibanez, Valencia, 46010

Site Contact

Inma Blasco

iblasco@incliva.es

961973527

Hospital Universitario Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Vall d'Hebron

Barcelona, , 08035

Site Contact

Elena G Cabanas, MD

egarralda@vhio.net

(+34) 93 274 60 00 #4846

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , 28040

Site Contact

Victor Moreno, MD

fjd@startmadrid.com

0034 91 550 48 00 #2805

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario HM Sanchinarro CIOCC

Madrid, , 28050

Site Contact

Esther Ordoñez

ciocc@startmadrid.com

91 756 78 25

Hospital Universitario Virgen del Rocio, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen del Rocio

Sevilla, , 41013

Site Contact

Esperanza Muñoz

espe.m.garcia@gmail.com

+34 600145696

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