for people ages 18-75 (full criteria)
at San Diego, California and other locations
study started
estimated completion
Principal Investigator
by Ezra Cohen



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.

Official Title

A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer


Head and Neck Cancer Cell Therapy T-cell Therapy SPEAR T-Cell MAGE-A4 ADP-A2M4 Immuno-oncology Head and Neck Neoplasms Pembrolizumab ADP-A2M4 in combination with pembrolizumab.


You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • Positive for any HLA-A*02 allele other than: one of the inclusion alleles,

HLA-A02:07P or HLA-A02 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.


  • University of California San Diego accepting new patients
    San Diego California 92093 United States
  • Providence Cancer Institute Franz Head and Neck Clinic accepting new patients
    Portland Oregon 97213 United States

Lead Scientist at UCSD


accepting new patients
Start Date
Completion Date
Phase 2
Study Type
Last Updated