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CAR T-cell Therapy
E7 TCR T Cell Therapy for HPV-Related Cancers
Phase 1 & 2
Recruiting
Led By Scott M Norberg, D.O.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable metastatic or refractory/recurrent HPV-16+ cancer determined by in situ hybridization (ISH) or a polymerase chain reaction (PCR)-based test
All patients must have received prior first line standard therapy or declined standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks, every 3 months x 3, every 6 months x 5 years, then as per pi discretion thereafter
Awards & highlights
Study Summary
This trial is testing a new therapy for HPV-associated cancers. Researchers will take a person's blood, remove certain white blood cells, and insert genes that make them to target cancer cells that have the HPV protein called E7. The genetically changed cells, called E7 TCR cells, are then given back to the person to fight the cancer.
Who is the study for?
Adults 18+ with HPV-16-associated cancers (cervical, vulvar, vaginal, penile, anal, oropharyngeal) who've tried standard treatments or declined them. Must have proper liver and kidney function, acceptable blood counts, no more than three treated brain metastases. HIV negative and not on immunosuppressants except for certain exceptions.Check my eligibility
What is being tested?
The trial tests E7 TCR cells therapy where patients' white blood cells are genetically modified to target cancer cells containing the HPV protein E7. It includes chemotherapy drugs Cyclophosphamide and Fludarabine followed by an infusion of these modified cells plus Aldesleukin shots to stimulate them.See study design
What are the potential side effects?
Possible side effects include reactions from the immune system attacking normal tissues (autoimmunity), symptoms from high-dose chemotherapy like nausea and hair loss, fatigue from Aldesleukin injections, increased risk of infections due to low white blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is HPV-16 positive and can be measured.
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I have either received or declined the first round of standard treatment.
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I am fully active or can carry out light work.
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My genetic test shows I am HLA-A*02 and HLA-A*02:01 positive.
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I am 18 years old or older.
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I do not have hepatitis B or C, or if I had hepatitis C, I am now virus-free.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 weeks, every 3 months x 3, every 6 months x 5 years, then as per pi discretion thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks, every 3 months x 3, every 6 months x 5 years, then as per pi discretion thereafter
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Determine a safe dose for E7 TCR cells plus aldesleukin
Phase II: Determine safety and effficacy of E7 TCR cells plus aldesleukin
Secondary outcome measures
To assess progression-free survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Phase IIExperimental Treatment4 Interventions
1 x 10 e11 E7 Cells that was determined in Phase I + aldesleukin
Group II: Arm 1: Phase IExperimental Treatment4 Interventions
Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR Cells at escalating doses, followed by aldesleukin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Aldesleukin
2012
Completed Phase 4
~1620
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,674 Total Patients Enrolled
1,393 Trials studying Carcinoma
387,035 Patients Enrolled for Carcinoma
Scott M Norberg, D.O.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
2,205 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active infections, bleeding disorders, or severe heart, lung, or immune system diseases.My cancer is HPV-16 positive and can be measured.I have either received or declined the first round of standard treatment.I am fully active or can carry out light work.I am on immunosuppressive drugs, but not for minor local uses or as a reaction premedication.My oxygen level is 95% or higher without extra oxygen.I am not pregnant, not breastfeeding, and if of childbearing age, have had a negative pregnancy test.My liver and kidney functions are within the required ranges.I am over 50 and have a serious heart rhythm problem.My genetic test shows I am HLA-A*02 and HLA-A*02:01 positive.I agree to use birth control during and up to 4 months after the study, and to test for HPV-16 before trying to get pregnant.It's been over 4 weeks since my last systemic therapy and I've recovered from recent minor surgeries.I have an autoimmune disease like Crohn's, but not a minor one like hypothyroidism.I am 18 years old or older.My heart function is normal despite past heart issues.I do not have any current infections.I have up to 3 brain metastases treated with surgery or radiosurgery and stable for 1 month.I do not have hepatitis B or C, or if I had hepatitis C, I am now virus-free.I have a primary immunodeficiency disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Phase I
- Group 2: Arm 2: Phase II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other research has been conducted that uses E7 TCR cells?
"There are currently 954 active clinical trials for E7 TCR cells, with 168 of them in Phase 3. While several of the trials are located in Philadelphia, Pennsylvania, there are a total of 28845 locations running studies for E7 TCR cells."
Answered by AI
Are we still enrolling participants for this experiment?
"According to the information available on clinicaltrials.gov, this trial is still enrolling patients. The listing for this trial was first posted on January 27th, 2017 and updated as recently as October 27th, 2020. They are currently seeking 180 participants from 1 site."
Answered by AI
What are E7 TCR cells typically used to treat?
"E7 TCR cells have been used to treat multiple sclerosis, however this conventional treatment can also be applied to leukemia, myelocytic, acute, retinoblastoma, and histiocytic lymphomas."
Answered by AI
How many people are eligible to participate in this experiment?
"The information available on clinicaltrials.gov verifies that this study is actively recruiting patients. This particular trial was first posted on January 27th, 2017 and updated October 27th, 2020. They are seeking a total of 180 participants from 1 location."
Answered by AI
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