Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT05225363

Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer

Led by City of Hope Medical Center · Updated on 2025-07-01

33

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase I trial tests the safety, side effects, and best dose of TAG72-chimeric antigen receptor (CAR) T cells in treating patients with epithelial ovarian cancer that remains despite treatment with platinum therapy (platinum resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize TAG72, a protein on the surface of tumor cells. These TAG72-specific T cells may help the body's immune system identify and kill TAG72+ cancer cells.

CONDITIONS

Official Title

Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability and willingness to sign written informed consent
  • Agreement to allow use of archival tumor tissue for testing, with possible exceptions
  • Age over 18 years
  • ECOG performance status 0 to 2 or Karnofsky score 70% or higher
  • Documented platinum-resistant epithelial ovarian cancer progressing within 6 months of platinum therapy or during recent platinum treatment
  • At least one measurable lesion or disease measurable by peritoneal cancer index at surgery
  • Documented TAG72-positive tumor expression (>1% cells with intensity 1 or more) by immunohistochemistry
  • Prior treatment with and failure or intolerance to taxanes, liposomal doxorubicin, or other beneficial agents unless investigator disagrees
  • No known contraindications to leukapheresis, steroids, or tocilizumab
  • Agreement to use birth control throughout treatment and for 3 months after final dose if of reproductive potential
  • Absolute neutrophil count of at least 1,000/mm3
  • Total serum bilirubin ≤1.5 times upper limit of normal (ULN), or ≤3.0 times ULN for Gilbert syndrome with direct bilirubin ≤1.5 times ULN
  • AST and ALT less than 3 times ULN (or less than 5 times ULN if liver metastasis present)
  • INR or aPTT ≤1.5 times ULN if not on therapeutic anticoagulation
  • Creatinine clearance at least 50 mL/min
  • Normal cardiac function by ECG without acute abnormalities
  • Left ventricular ejection fraction over 40%
  • Negative QuantiFERON-TB Gold or equivalent test
Not Eligible

You will not qualify if you...

  • Not recovered from toxicities of prior therapy
  • Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy excluded)
  • History of allergic reactions to similar compounds or study agents
  • History or current pneumonitis requiring steroids
  • Signs or symptoms of bowel obstruction
  • History of inflammatory bowel disease or gastrointestinal perforation
  • History of intra-abdominal abscess within 3 months
  • Known peritoneal adhesions preventing intraperitoneal catheter placement
  • Clinically significant arrhythmia unstable within 2 weeks before consent
  • History of optic neuritis, central nervous system inflammatory disease, or seizure disorder
  • Known bleeding disorders
  • History of stroke or intracranial hemorrhage within 6 months before consent
  • History of other malignancies except cured with no active disease for 3 years and certain skin cancers
  • Uncontrolled active infection
  • Active hepatitis B or C infection
  • HIV infection
  • Any condition that contraindicates study participation due to safety concerns
  • Massive ascites requiring paracentesis evaluated individually
  • Recent or planned therapies not stopped per washout requirements
  • Inability to comply with study procedures or logistics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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Research Team

L

Lorna Rodriguez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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