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CAR T-cell Therapy

HPV-Specific T Cell Therapy for Recurrent/Metastatic Cancer

Q: What is the limit of participants in this clinical experiment?

Affirmative. Clinicaltrials.gov data reveals that this research study, which was first posted on October 18th 2023, is actively recruiting volunteers. There are 24 slots available at a single medical center for the trial's participants.

Q: Are there still open positions for participating in this trial?

According to the clinicaltrials.gov page, this trial is currently recruiting individuals as of November 1st 2023. The study was first made available on October 18th 2023.

Q: What primary goals are being pursued through this research endeavor?

This clinical trial, lasting 12 months in duration, will be measuring the Maximum Tolerated Dose (MTD) of Allogeneic CD4+ T cell Infusion. Secondary outcomes include ascertaining the Incidence of acute graft versus host disease by using a consensus conference clinical grading system and determining the Overall Response to allogeneic CD4+ T cell Infusion and allogeneic BMT based off RECIST 1.1 criteria at 2, 6 ,and 12 months post-transplantation/infusions as well as gauging overall survival with Kaplan-Meier curves and 95% confidence intervals.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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+.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 6Eligibility criteria met

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Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,896 Total Patients Enrolled

PapiVax Biotech, Inc.OTHER

4 Previous Clinical Trials

190 Total Patients Enrolled

Tanguy Seiwert, MDPrincipal InvestigatorJohns Hopkins Sidney Kimmel Comprehensive Cancer Center

3 Previous Clinical Trials

78 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the limit of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov data reveals that this research study, which was first posted on October 18th 2023, is actively recruiting volunteers. There are 24 slots available at a single medical center for the trial's participants."

Answered by AI

Are there still open positions for participating in this trial?

"According to the clinicaltrials.gov page, this trial is currently recruiting individuals as of November 1st 2023. The study was first made available on October 18th 2023."

Answered by AI

What primary goals are being pursued through this research endeavor?

"This clinical trial, lasting 12 months in duration, will be measuring the Maximum Tolerated Dose (MTD) of Allogeneic CD4+ T cell Infusion. Secondary outcomes include ascertaining the Incidence of acute graft versus host disease by using a consensus conference clinical grading system and determining the Overall Response to allogeneic CD4+ T cell Infusion and allogeneic BMT based off RECIST 1.1 criteria at 2, 6 ,and 12 months post-transplantation/infusions as well as gauging overall survival with Kaplan-Meier curves and 95% confidence intervals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers

2023. "Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04713046.