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

Starting soon · Phase 1/Phase 2

Conditions studied: Ovarian Cancer, Advanced Malignant Solid Tumor

In brief

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 facts

Study ID

NCT07389239

Run by

University of Chicago

People needed

24

Starts

2026-06-23

Expected to finish

2031-12-10

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects (18 years and older) with histologically or cytologically of advanced (metastatic or inoperable) advanced solid tumors.
• Tumor (either an archival specimen or a fresh biopsy) shows NY-ESO-1 expression of 1+ by IHC (H-score). NY-ESO-1 expression must be confirmed by central validated assay.
• Patients with NY-ESO-1 expressing solid tumors will be included. Patients must have received, been intolerant of, or been ineligible to receive at least 2 lines of the current standard of care therapy including but not limited to chemotherapy, immunotherapy and/or targeted therapy when appropriate (e.g. Atezolizumab is approved for use in patients with alveolar soft part sarcoma) according to their disease:
• Inoperable or metastatic (advanced) ovarian, primary peritoneal or fallopian tube carcinoma:
• Has received platinum containing chemotherapy and has platinum refractory or resistant disease that has progressed on second line therapy
• If platinum sensitive disease, should have received ≥2 lines of chemotherapy.
• May have received PARP inhibitors, bevacizumab or other targeted VEGF inhibitor therapy
• Inoperable or metastatic (advanced) soft tissue sarcoma:
• Subjects must have previously received either an anthracycline or ifosfamide containing regimen.
• Gastrointestinal stromal tumors are eligible, but only must have previously received KIT-targeted therapy if a sensitizing mutation is present.
• Angiosarcomas are eligible, but only must have received prior taxane-based chemotherapy
• Urothelial carcinoma:
• Subjects must have received or refused 1 prior platinum-based therapy for the treatment of metastatic or locally advanced unresectable disease.
• Subjects who are not eligible for a platinum-containing regimen or who have progressed on a platinum-containing regimen
• Subjects may have received an anti-PD-l/PDL1 checkpoint inhibitor
• Metastatic castration-resistant adenocarcinoma of the prostate (CRPC) defined as serum testosterone level ≤ 50 ng/dL with prior surgical castration or ongoing androgen deprivation, with progressive disease:
• Progressive disease is defined by rising prostate specific antigen (PSA) or radiographic imaging according to the PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration
• At least one prior chemotherapy regimen in the metastatic setting
• Prior therapy with at least one standard 17α lyase inhibitor or second generation anti-androgen therapy for the treatment of castrate- resistant prostate cancer.
• Breast Cancer
• Prior standard of care regimens with at least one anthracycline or taxane-based regimen in either an adjuvant or metastatic setting unless intolerant or clinically not indicated. For ER positive HER2 negative cancer must have progressed on therapy with CDK 4/6 inhibitor combination. Prior hormonal therapy or Human epidermal growth factor receptor-2 (HER2) targeted therapies are allowed.
• Melanoma
• A PD-1 or PD-L1 inhibitor (with or without a cytotoxic T lymphocyte-associated protein 4 [CTLA-4] inhibitor). Patients with an actionable mutation (e.g., BRAF) must have received at least one targeted therapy.
• Non-small cell lung cancer
• A PD-1 or PD-L1 inhibitor and for patients with a PD-L1 tumor proportion score (TPS) < 50%, a platinum-based chemotherapy regimen. Patients with non-squamous NSCLC with an actionable mutation (e.g., EGFR, ALK, ROS-1) must have received at least one targeted therapy. A checkpoint inhibitor is not required for patients with actionable mutations.

You may not qualify if…

• Patients who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure with New York Heart Association class III or IV disease, patients with a LVEF < 45%, a myocardial infarction within 6 months prior to study entry or a history of myocarditis, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with active autoimmune disease requiring doses of corticosteroids of ≥ 10 mg/day of prednisone (or its equivalent) or other immunosuppressive treatments.
• History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
• Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (inhaled or topical steroids at standard doses or isolated use of steroids as premedication for medical procedures to minimize allergic reaction [e.g. CT scan dye] are allowed).
• Known cases of clinically active brain metastases (brain MRI as clinically indicated) because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment.
• Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
• Pregnancy or breast-feeding. Patients must be surgically sterile or be postmenopausal for two years,or must agree to use effective contraception during the period of treatment and after as stated in inclusion 3.1.9. Patients with reproductive potential must have a negative pregnancy test (serum/urine) within 48 hours from starting the conditioning chemotherapy.
• Lack of availability of a patient for immunological and clinical follow-up assessment.
• Patients with pulmonary function test abnormalities as evidenced by a FEV1/FVC<70% of predicted for normality will be excluded.
• Patients with baseline O2 saturation <90% on room air.
• Patients with history of pneumonitis and/or interstitial lung disease.
• Patients with ascites, pleural or pericardial effusions which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months.
• Patients that have had "any major surgical procedure (planned or anticipated) within 4 weeks from the first dose of study treatment(s).
• Patients who have received any live vaccines within 30 days prior to enrollment.

Where it is running

• University of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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