Actively Recruiting
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
Led by Christian Hinrichs · Updated on 2026-02-27
15
Participants Needed
2
Research Sites
59 weeks
Total Duration
On this page
Sponsors
C
Christian Hinrichs
Lead Sponsor
I
Iovance Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival. This study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years. Participants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.
CONDITIONS
Official Title
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed carcinoma of a primary tumor site as specified in the protocol
- Tumor positive for HPV16 genotype confirmed by certified laboratory testing
- Presence of HLA-A*02:01 allele confirmed by certified laboratory testing prior to apheresis
- Measurable disease per RECIST 1.1 or PERCIST criteria
- Age over 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Negative pregnancy test for women under 55 or those with recent menstrual periods; not required for women with bilateral oophorectomy or hysterectomy
- Men and women of child-bearing potential must agree to use adequate contraception before and for four months after treatment
- Seronegative for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody; if hepatitis C antibody positive, must have negative antigen test
- Adequate organ and marrow function as defined by specific blood counts and laboratory values
- Ability to understand and sign informed consent
- Agreement to participate in gene therapy long term follow-up and biospecimen collection studies
- Recovery to Grade 1 or less toxicities from any minor surgical procedures within past three weeks
You will not qualify if you...
- Prior systemic therapy or definitive chemoradiation for the cancer treated in this study
- Current treatment with another investigational agent
- History of severe allergic reactions to similar compounds used in this study
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
- HLA-A*02:01 damaging mutation or allele loss detected
- Left ventricular ejection fraction (LVEF) less than or equal to 45%
- Clinically significant cardiac arrhythmias or age over 50 requiring cardiac evaluation
- Baseline oxygen saturation less than 92% on room air
- Breastfeeding mothers if treated with E7 TCR T cells
- Systemic immunodeficiency including HIV or primary immunodeficiency
- Use of immunosuppressive drugs including corticosteroids unless meeting specific criteria
- Severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus
- Prior or concurrent malignancies unlikely to interfere with study assessments
- Receipt of a live vaccine within 30 days prior to enrollment
- Investigator judgment that participation is not in the subject's best interest or may jeopardize safety or data integrity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
2
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
T
Tobi Adewale
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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