Summary

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

Description

Summary

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

Keywords

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.

Eligibility

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 cytogenetics.
  • Checkpoint inhibitor naïve and may have received prior platinum containing chemotherapy regimen.
  • Measurable disease according to RECIST v1.1.
  • HLA-A*02 positive
  • Tumor shows MAGE-A4 expression confirmed by central laboratory.
  • Tumors express PD-L1 [CPS ≥1]
  • 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.

Locations

  • 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

  • Ezra Cohen, MD
    Professor, Medicine. Authored (or co-authored) 189 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Adaptimmune
ID
NCT04408898
Phase
Phase 2
Study Type
Interventional
Last Updated