Genetically Modified T Cells + Decitabine for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Must not be taking: Corticosteroids, Hydroxyurea, Immunomodulators

Disqualifiers: Brain metastases, Prior malignancy, Active infection, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

9 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies a treatment combining enhanced immune cells and a drug to target difficult-to-treat ovarian and related cancers. The approach aims to improve the body's ability to find and destroy cancer cells.

Research Team

Emese Zsiros

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for patients with recurrent or refractory ovarian, primary peritoneal, or fallopian tube cancer. Participants must have HLA-A*02;01 positivity, good performance status (ECOG 0-1), life expectancy over 4 months, adequate organ function and blood counts, measurable disease by irRECIST criteria, and be at least 4 weeks out from prior treatments. Women of childbearing potential must agree to use effective contraception.

Inclusion Criteria

I agree to use effective birth control methods during and after the study for several years.

Leukocytes >= 3 x 10^9/L

Patient must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

I do not have any ongoing illnesses or social situations that would prevent me from following the study's requirements.

I do not have active hepatitis C or have a recent test showing I'm clear of it.

Lack of availability of a patient for immunological and clinical follow-up assessment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive decitabine IV daily over 1 hour on days -8 to -6, cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered NY-ESO-1-specific T lymphocytes IV and IP on day 0, followed by low-dose IL-2 for 2 weeks from Day 1 to Day 14.

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 years

Monthly at 3-9 months, every 6 months for 4 years, then annually

Treatment Details

Interventions

• Decitabine
• Genetically Engineered NY-ESO-1-specific T Lymphocytes

Trial Overview The trial is testing the safety of genetically modified T cells designed to target NY-ESO-1 protein on tumor cells combined with Decitabine in patients whose cancer has returned or hasn't responded to treatment. Patients' own T cells are collected and engineered before being reintroduced into their body alongside Decitabine to potentially enhance the immune response against cancer.

Participant Groups

Group I: Treatment (decitabine, genetically modified T cells) Experimental Treatment 5 Interventions

COURSE 1: Patients receive decitabine IV daily over 1 hour on days -8 to -6, cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered NY-ESO-1-specific T lymphocytes IV and IP on day 0. Patients also receive aldesleukin SC BID on days 1-14..

Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dacogen for:

• Acute myeloid leukemia
• Myelodysplastic syndromes

Approved in United States as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Canada as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+