Purpose

This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 and <75 years - Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by histology cytology. - Checkpoint inhibitor naïve and indicated for pembrolizumab or currently receiving pembrolizumab (monotherapy). May have received prior platinum containing chemotherapy regimen or checkpoint inhibitor therapy. - Measurable disease according to RECIST v1.1. - HLA-A*02 positive by central laboratory. - Tumor shows MAGE-A4 expression confirmed by central laboratory. - ECOG Performance Status of 0 or 1. - Left ventricular ejection fraction (LVEF) ≥50%. Note: other protocol defined Inclusion criteria may apply

Exclusion Criteria

  • Positive for any HLA-A*02 allele other than: one of the inclusion alleles, HLA-A*02:07P or HLA-A*02 null alleles - History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study or history of severe hypersensitivity to another monoclonal antibody. - History of autoimmune or immune mediated disease - Leptomeningeal disease, carcinomatous meningitis or 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 Exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ADP-A2M4 T cells in combination with pembrolizumab
  • Genetic: ADP-A2M4 in combination with pembrolizumab.
    Single infusion of autologous genetically modified ADP-A2M4 Dose: 1.0 x109 to 10x109 transduced cells by a single intravenous infusion Repeat doses of pembrolizumab every 3 weeks. Dose: 200mg

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37212
Contact:
Tom Leonard-Martin
thomas.leonard-martin@vumc.org

More Details

Status
Recruiting
Sponsor
Adaptimmune

Study Contact

Adaptimmune Patient Enquiries
2158259260
patients@adaptimmune.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.