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

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