TCR-engineered T cells targeting E7 for patients with metastatic HPV-associated epithelial cancers.
Nisha B Nagarsheth, Scott M Norberg, Andrew L Sinkoe...
https://pubmed.ncbi.nlm.nih.gov/33558725Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05639972
E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers Feasibility Study
Led by Christian Hinrichs · Updated on 2026-02-27
15
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Christian Hinrichs
Lead Sponsor
I
Iovance Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of using a single dose of E7 TCR-T cells as an initial treatment before standard therapies like chemoradiation or surgery for people with locoregionally advanced HPV-associated cancers. This study aims to see if this approach can shrink or eliminate tumors to help with definitive treatment and improve survival. Participants must have HPV-16-positive tumors and a specific genetic marker, HLA-A*02:01, to be eligible. Participants will have their T cells collected through a procedure called apheresis, which will then be genetically modified to produce E7 TCR-T cells. About one week later, they will receive a preparative treatment with cyclophosphamide and fludarabine to prepare their body, followed by a single intravenous infusion of their own E7 TCR-T cells. Within 24 hours after this infusion, participants will receive up to three doses of aldesleukin intravenously every eight hours while staying in the hospital. After treatment, participants return to their main cancer care team for standard therapy. Participants will be monitored with follow-up visits at 3 and 6 weeks after treatment to check safety and tumor response using imaging scans. If tumors do not respond, definitive therapy may start sooner. Researchers will also track disease-free survival at 2 and 5 years. The total participation time includes these initial weeks plus long-term follow-up for safety and effectiveness assessments.
CONDITIONS
Brief Title
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed carcinoma of a primary tumor site with stage as specified in the study protocol.
- Tumor must be HPV16 genotype positive as determined by certified laboratory testing.
- Presence of HLA-A*02:01 allele confirmed by certified laboratory testing before apheresis.
- Measurable disease according to RECIST Version 1.1 or PERCIST criteria.
- Age over 18 years.
- ECOG performance status of 0 or 1 at screening.
- Women under 55 and women who have menstruated in the last 12 months must have a negative pregnancy test; not required if bilateral oophorectomy or hysterectomy performed.
- Men and women of child-bearing potential must agree to use effective 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, RT-PCR test must be negative).
- Adequate organ and marrow function as defined by specific blood count and chemistry thresholds.
- Ability to understand and sign informed consent.
- Agreement to participate in gene therapy long-term follow-up and biospecimen collection studies.
- Minor surgical procedures allowed within past three weeks if toxicities have resolved to Grade 1 or less.
You will not qualify if you...
- Prior systemic therapy or definitive chemoradiation for the cancer being treated.
- Current treatment with another investigational agent.
- History of severe allergic reactions to similar compounds used in this study.
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance.
- Presence of HLA-A*02:01 damaging mutation or allele loss.
- Left ventricular ejection fraction (LVEF) less than or equal to 45%.
- Significant arrhythmias or age over 50 requiring cardiac evaluation.
- Baseline oxygen saturation below 92% on room air unless improved.
- Breastfeeding mothers must discontinue breastfeeding if treated.
- Systemic immunodeficiency including HIV or primary immune deficiencies.
- Use of immunosuppressive drugs including corticosteroids unless allowed.
- Severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, pancreatitis, or lupus.
- Recent live vaccine within 30 days prior to enrollment.
- Any condition that the investigator judges unsafe for study participation or that may affect data integrity.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 2 weeks including apheresis, conditioning, and infusion
Participants undergo apheresis to collect cells for gene engineering. One week later, they receive a conditioning regimen of cyclophosphamide and fludarabine, followed by a single infusion of E7 TCR-T cells and adjuvant high-dose aldesleukin administered every 8 hours for up to 3 doses as an inpatient.
1 apheresis visit, 1 conditioning and infusion visit, and up to 3 inpatient aldesleukin doses
Follow-up
Duration - 6 weeks
Participants return for follow-up visits at 3 weeks and 6 weeks after treatment to monitor tumor response and overall health. Tumor response is assessed by imaging at the 6-week visit. Participants are then referred back to their primary oncology team for further treatment.
2 visits (in-person) at 3 and 6 weeks post-treatment
Long-term Monitoring
Duration - 5 years
Participants are followed to determine 2- and 5-year disease free survival after completion of treatment.
Follow-up visits over 2 and 5 years as part of disease monitoring
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
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Research Team
T
Tobi Adewale
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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