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

Must not have

Concurrent opportunistic infections

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)

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

No Placebo-Only Group

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.

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.

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 below

Select...

My cancer is HPV-16 positive and can be measured.

Select...

I have either received or declined the first round of standard treatment.

Select...

I am fully active or can carry out light work.

Select...

My genetic test shows I am HLA-A*02 and HLA-A*02:01 positive.

Select...

I am 18 years old or older.

Select...

I do not have hepatitis B or C, or if I had hepatitis C, I am now virus-free.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any current infections.

Select...

I have a primary immunodeficiency disorder.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks, every 3 months x 3, every 6 months x 5 years, then as per pi discretion thereafter for reporting.