Actively Recruiting
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Led by Christian Hinrichs · Updated on 2026-02-27
20
Participants Needed
3
Research Sites
199 weeks
Total Duration
On this page
Sponsors
C
Christian Hinrichs
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.
CONDITIONS
Official Title
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed metastatic or recurrent HPV-16 positive cancer by histology or cytology
- Tumor confirmed to have HPV16 genotype by testing in a certified laboratory
- Presence of HLA-A*02:01 allele confirmed by certified laboratory testing
- Measurable disease according to RECIST Criteria Version 1.1
- Age 18 years or older
- ECOG performance status of 0 or 1 at screening
- Received or declined prior first-line standard therapy
- Standard first and second-line therapies must have been offered and formally declined
- Up to three brain metastases treated with surgery or radiosurgery, stable and fully recovered
- Negative pregnancy test for women under 55 or those with recent menstrual periods, unless surgically sterile
- Agreement to use effective contraception before and for four months after treatment
- Negative for HIV, hepatitis B antigen, and hepatitis C antibody, with confirmation of no active hepatitis C infection if antibody positive
- Adequate organ and marrow function as defined by specific blood counts and biochemical levels
- More than four weeks since prior systemic therapy with resolved or stable side effects
- Ability and willingness to provide informed consent
- Agreement to participate in long-term gene therapy follow-up and biospecimen collection studies
You will not qualify if you...
- Uncontrolled illnesses such as active infection, unstable heart conditions, or psychiatric/social issues affecting study compliance
- History of severe allergic reactions to similar agents used in this study
- History of coronary revascularization or ischemic symptoms without a normal cardiac stress test
- Left ventricular ejection fraction (LVEF) less than or equal to 45%
- Significant arrhythmias or age over 50 requiring cardiac evaluations
- Oxygen saturation less than 92% on room air unless improved
- Presence of HLA-A*02:01 damaging mutation or allele loss
- Breastfeeding during treatment with E7 TCR T cells
- Systemic immunodeficiency including HIV or primary immunodeficiency
- Use of immunosuppressive drugs including corticosteroids unless allowed
- Severe autoimmune diseases like Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, pancreatitis, or lupus
- Prior or concurrent malignancies that could interfere with safety or efficacy assessments except certain low-risk cancers
- Receipt of live vaccine within 30 days prior to enrollment
- Investigator judgment that participation is unsafe or could compromise study integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
3
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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