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

NCT07389239 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB25-1721
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer; Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (1)

• To evaluate autologous in the number of participants with treatment-related adverse events.

  To evaluate the safety and tolerability of the autologous NY-ESO-1/ dnTGFβRII engineered T cell therapy in combination with decitabine and low-dose IL2 in patients with advanced malignancies. The irRECIST will be used for tumor response assessment performed at 6 weeks, 3 months, 6 months and 9 months.

  2 years

Secondary Outcomes (3)

• To evaluate modified cells using immune- related Response Evaluation Criteria in Solid Tumors (irRECIST).

  2 years

• Objective response rate (ORR) tumor effect

  6 weeks, 3 months, 6 months and 9 months.

• Progression free survival (PFS) tumor effect

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 9 months.

Study Arms (4)

Lead-in cohort

EXPERIMENTAL

Up to 6 participants will be enrolled to this arm to determine if the study treatment is safe.

Drug: Decitabine; Drug: Cyclophosphamide Conditioning; Biological: NY-ESO-1 TCR/ dnTGFβRII; Drug: Aldesleukin

Dose Level -1

EXPERIMENTAL

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.

Drug: Decitabine; Drug: Cyclophosphamide Conditioning; Biological: NY-ESO-1 TCR/ dnTGFβRII; Drug: Aldesleukin

Expansion Cohort A (Ovarian)

EXPERIMENTAL

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.

Drug: Decitabine; Drug: Cyclophosphamide Conditioning; Biological: NY-ESO-1 TCR/ dnTGFβRII; Drug: Aldesleukin

Expansion Cohort B (Other Solid Tumors)

EXPERIMENTAL

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.

Drug: Decitabine; Drug: Cyclophosphamide Conditioning; Biological: NY-ESO-1 TCR/ dnTGFβRII; Drug: Aldesleukin

Interventions

NY-ESO-1 TCR/ dnTGFβRII BIOLOGICAL

The dose of NY-ESO-1 TCR/ dnTGFβRII to be tested will vary depending on assigned arm.

Dose Level -1; Expansion Cohort A (Ovarian); Expansion Cohort B (Other Solid Tumors); Lead-in cohort

Aldesleukin DRUG

Aldesleukin taken by mouth500,000 IU/m2 SC BID; Days +1 to +10

Also known as: (IL-2)

Dose Level -1; Expansion Cohort A (Ovarian); Expansion Cohort B (Other Solid Tumors); Lead-in cohort

Decitabine DRUG

Decitabine taken by mouth 15 mg/m2/day x 5 days, IV; Days -10 to -6

Dose Level -1; Expansion Cohort A (Ovarian); Expansion Cohort B (Other Solid Tumors); Lead-in cohort

Cyclophosphamide Conditioning DRUG

Cyclophosphamide Conditioning will be 45 mg/kg x 2 days IV; Days -4 \& -3

Dose Level -1; Expansion Cohort A (Ovarian); Expansion Cohort B (Other Solid Tumors); Lead-in cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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).
• Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Decitabine; aldesleukin; Interleukin-2

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Daniel Olson

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake Intake

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 5, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): December 10, 2031
• Study Completion (Estimated): December 10, 2031
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)