Gene and Vaccine Therapy for Cancer

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 35

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial will examine whether genetically reprogramming a patient's disease fighting white blood cells may build an immune response to kill cancer cells that express the NY-ESO-1 protein. In this study, this genetic therapy will be given during a stem cell transplant along with a vaccine therapy. The vaccine will be made using the NY-ESO-1 protein and may help to stimulate the engineered immune response to tumor cells.

Research Team

Antonio Ribas, MD, PhD

Principal Investigator

Jonsson Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am HLA-A*0201 positive.

I am willing to undergo at least two tumor biopsies.

A minimum of one measurable lesion meeting RECIST criteria

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Patients receive cyclophosphamide and fludarabine phosphate intravenously to prepare for transplant

5 days

Daily visits for 5 days

Transplant and Initial Treatment

Patients receive NY-ESO-1 TCR transduced autologous PBMC and NY-ESO-1 peptide pulsed dendritic cell vaccine therapy, along with aldesleukin

30 days

Multiple visits including days 0, 1, 14, and 30

Extended Vaccine Therapy

Patients may receive additional doses of NY-ESO-1 peptide pulsed dendritic cell vaccine therapy

After day 90

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Follow-up at 30, 45, 60, and 75 days; every 3 months for 2 years; every 6 months for 3 years; and annually thereafter

Treatment Details

Interventions

• Dendritic cell vaccine therapy
• NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL

Trial Overview 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.

Participant Groups

Group I: Treatment (gene and vaccine therapy) Experimental Treatment 8 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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+