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CAR T-cell Therapy

HPV-Specific T Cell Therapy for Recurrent/Metastatic Cancer

Phase 1 & 2

Recruiting

Led By Tanguy Seiwert, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female ≥ 18 years of age

Patients with an FDA-approved indication to receive an anti-programmed cell death protein-1 (PD-1) or anti-programmed death-ligand1 (PD-L1) monoclonal antibody must have received at least one cycle of this therapy prior to receiving treatment on this trial

Must not have

History of (non-infectious) pneumonitis that required steroids or current pneumonitis

Prior treatment with HPV T cells

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a therapeutic HPV vaccine and bone marrow/lymphocyte infusion can treat a recurrent/metastatic HPV16+ cancer.

Who is the study for?

Adults with recurrent or metastatic HPV16+ cancers who've had platinum-based treatment, an ECOG status <2, and a haploidentical related donor. They must have tried anti-PD-1/PD-L1 therapy if indicated, measurable disease per RECIST 1.1, and adequate organ function. Exclusions include those with curable local disease options, recent immunosuppressive treatments, active autoimmune diseases or infections, pregnancy/breastfeeding without contraception use.

What is being tested?

The trial is testing the safety and effectiveness of two approaches using immune cells from vaccinated relatives: either a non-myeloablative bone marrow transplant or an infusion of CD8-depleted T cells to treat adults with HPV16+ cancers that have come back or spread.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response such as inflammation in various organs due to infused T-cells targeting cancerous tissues; complications from bone marrow transplantation including infection risk; and typical symptoms associated with cellular therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had at least one cycle of PD-1 or PD-L1 therapy.

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I have been treated with a platinum-based chemotherapy before.

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I have a family donor who is a partial HLA match for me.

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I can do most of my daily activities without help.

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My cancer is incurable, has returned, or spread and is HPV16+.

Exclusion Criteria

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

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I have had pneumonitis treated with steroids or have it now.

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I have been treated with HPV T cells before.

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I have a history of HIV, active hepatitis B, or hepatitis C.

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I am currently on medication for an infection.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have not received a live vaccine in the last 30 days.

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I need medication to maintain my blood pressure or a machine to help me breathe.

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My condition can be treated with the goal of curing it.

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I have received a specific immune therapy within the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of Allogeneic CD4+ T cell Infusion

Safety as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary study objectives

Incidence of acute graft versus host disease (GVHD)

Number of toxicities as assessed by the NCI CTCAE version 5.0

Overall Response of allogeneic CD4+ T cell Infusion and allogeneic BMT

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: CD8-depleted donor lymphocyte infusion (DLI) per dose escalation schemeExperimental Treatment1 Intervention

CD8-depleted donor lymphocyte infusion per dose escalation scheme from a haploidentical relative after vaccination with a therapeutic HPV vaccine series.

Group II: Allogeneic bone marrow transplantExperimental Treatment1 Intervention

non-myeloablative allogeneic bone marrow transplant (BMT) from a haploidentical relative after vaccination with a therapeutic HPV vaccine series.

0 / 15Eligibility criteria met