A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies.

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07389239
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    Decitabine taken by mouth 15 mg/m2/day x 5 days, IV; Days -10 to -6
  • Cyclophosphamide Conditioning — DRUG
    Cyclophosphamide Conditioning will be 45 mg/kg x 2 days IV; Days -4 \& -3
  • NY-ESO-1 TCR/ dnTGFβRII — BIOLOGICAL
    The dose of NY-ESO-1 TCR/ dnTGFβRII to be tested will vary depending on assigned arm.
  • Aldesleukin — DRUG
    Aldesleukin taken by mouth500,000 IU/m2 SC BID; Days +1 to +10

Study Details

This phase I/IIA trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens.

Key Dates

Start date
Jun 23, 2026
Status verified
Feb 2026
Primary completion
Dec 10, 2031
Completion
Dec 10, 2031

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Lead-in cohort
    Up to 6 participants will be enrolled to this arm to determine if the study treatment is safe.
  • Experimental: Dose Level -1
    If the dose tested in Lead in cohort is not found to be safe, the dose of the NY-ESO-1 TCR/ dnTGFβRII cell dose will be lowered and up to 6 participants will be enrolled to this arm.
  • Experimental: Expansion Cohort A (Ovarian)
    Up to 6 participants with Ovarian Cancer will be enrolled to this arm after the safe dose of NY-ESO-1 TCR/ dnTGFβRII cell is found.
  • Experimental: Expansion Cohort B (Other Solid Tumors)
    Up to 6 participants with other solid tumor cancers will be enrolled to this arm after the safe dose of NY-ESO-1 TCR/ dnTGFβRII cell is found.

Primary Outcome Measure

To evaluate autologous in the number of participants with treatment-related adverse events. [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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