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Virus Therapy

Gene and Vaccine Therapy for Cancer

Phase 2

Waitlist Available

Led By Antonio Ribas, MD, PhD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

HLA-A*0201 (HLA-A2.1) positivity by molecular subtyping

Must be willing and able to accept at least two tumor biopsies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Study Summary

This trial will test whether genetically engineering a patient's white blood cells to create an immune response to the NY-ESO-1 protein can kill cancer cells expressing that protein. The therapy will be given during a stem cell transplant, along with a vaccine made using the NY-ESO-1 protein.

Who is the study for?

This trial is for patients over 16 with advanced cancers expressing NY-ESO-1 protein, HLA-A*0201 positive, and no alternative treatments available. They must have good kidney function, be willing to undergo biopsies and leukapheresis, and not have had recent cancer treatments or immunosuppressants.Check my eligibility

What is being tested?

The study tests a gene therapy that reprograms white blood cells to fight cancer along with a vaccine made from the NY-ESO-1 protein. It aims to see if this combination can boost the immune system's response against tumor cells during stem cell transplant.See study design

What are the potential side effects?

Possible side effects include reactions related to genetic therapy or vaccine administration such as flu-like symptoms, fatigue, fever, chills, and potential increased risk of infection due to immune system modification.

Eligibility Criteria

Inclusion Criteria

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

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I am HLA-A*0201 positive.

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I am willing to undergo at least two tumor biopsies.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is advanced and there are no other treatment options that could improve my survival.

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I have a tumor that can be safely biopsied.

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My cancer tests positive for NY-ESO-1.

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I am willing to undergo at least two leukapheresis procedures.

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I am 16 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Clinical response

Secondary outcome measures

NY-ESO-1 TCR transgenic cell persistence, quantitated in PBMC samples

NY-ESO-1 TCR transgenic cell tumor trafficking

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (gene and vaccine therapy)Experimental Treatment8 Interventions

CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on days -5 to -4 and fludarabine phosphate IV over 30 minutes on days -4 to -1. TRANSPLANT: Patients receive NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL IV on day 0. Patients also receive NY-ESO-1 (157-165) peptide pulsed dendritic cell vaccine therapy ID on days 1, 14, and 30 and aldesleukin SC BID on days 1-14. Patients may receive 3 additional doses of NY-ESO-1 (157-165) peptide pulsed dendritic cell vaccine therapy after day 90.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

aldesleukin

2000

Completed Phase 3

~2340

cyclophosphamide

1994

Completed Phase 3

~8140

dendritic cell vaccine therapy

2010

Completed Early Phase 1

~20

fludeoxyglucose F 18

2005

Completed Phase 3

~3970

positron emission tomography

2010

Completed Phase 2

~1370

fludarabine phosphate

2000

Completed Phase 3

~2660

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

361 Previous Clinical Trials

27,776 Total Patients Enrolled

Antonio Ribas, MD, PhDPrincipal InvestigatorJonsson Comprehensive Cancer Center

Media Library

NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01697527 — Phase 2

Cancer Research Study Groups: Treatment (gene and vaccine therapy)

Cancer Clinical Trial 2023: NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL Highlights & Side Effects. Trial Name: NCT01697527 — Phase 2

NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01697527 — Phase 2

Frequently Asked Questions

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

How many research subjects are being enrolled in this trial?

"This study is not recruiting at this time, however it was updated as recently as January 5th, 2022. There are 2462 other clinical trials for cancer patients and 954 dendritic cell vaccine therapy trials that are currently enrolling patients if you are interested."

Answered by AI

Are there any more patients needed to participate in this research?

"While this specific study isn't looking for new participants, the data on clinicaltrials.gov shows that it was last updated on January 5th, 2022. There are 3416 other trials that are actively recruiting patients."

Answered by AI

What is the FDA's opinion on dendritic cell vaccines as a treatment?

"Given that this is a Phase 2 trial, there is only partial evidence of safety for dendritic cell vaccine therapy. Consequently, it received a score of 2."

Answered by AI

What is dendritic cell vaccine therapy used to treat?

"Dendritic cell vaccine therapy can be used to target and treat leukemia, myelocytic, acute, retinoblastoma, and other forms of cancer."

Answered by AI

What other research projects have looked at dendritic cell vaccine therapy?

"Dendritic cell vaccine therapy is being trialled in 954 different studies, 168 of which are Phase 3 trials. Although most of these experiments are conducted in Philadelphia, Pennsylvania, there are28845 locations running these tests."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

A Pilot Trial of the Combination of Transgenic Ny-eso-1–reactive Adoptive Cellular Therapy with Dendritic Cell Vaccination with or Without Ipilimumab

Nowicki, Theodore S., Beata Berent-Maoz, Gardenia Cheung-Lau, Rong Rong Huang, Xiaoyan Wang, Jennifer Tsoi, Paula Kaplan-Lefko, et al.. 2019. “A Pilot Trial of the Combination of Transgenic Ny-eso-1–reactive Adoptive Cellular Therapy with Dendritic Cell Vaccination with or Without Ipilimumab”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-18-3496.

clinicaltrials.govStudy

Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies

2012. "Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01697527.