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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 belowSelect...
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
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
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,742 Total Patients Enrolled
Antonio Ribas, MD, PhDPrincipal InvestigatorJonsson Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any cancer treatment in the last month.I have a history of chronic gut conditions like IBD or celiac disease.I may need steroids or drugs that weaken my immune system.I have hepatitis B or C and it is currently harming my liver.I do not have dementia or significant changes in my mental status.I am HLA-A*0201 positive.I am willing to undergo at least two tumor biopsies.I have undergone 3 or more treatments that could affect my bone marrow.My liver and bone marrow are working well, as tested in the last 2 months.I have active cancer spread to my brain.My heart's pumping ability is normal and I have no serious heart rhythm problems.I am 50 or older with a heart function (LVEF) below 45%.I have no restrictions on my previous treatments.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is advanced and there are no other treatment options that could improve my survival.I have a tumor that can be safely biopsied.My cancer tests positive for NY-ESO-1.I am willing to undergo at least two leukapheresis procedures.I am 16 years old or older.My autoimmune or chronic inflammatory disease is not currently active.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gene and vaccine therapy)
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.
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