Actively Recruiting
A Phase 1 Study of TAG72-Targeting CAR T Cells for Advanced Epithelial Ovarian Cancer
Led by City of Hope Medical Center · Updated on 2025-07-01
33
Participants Needed
1
Research Sites
34 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
Researchers are evaluating TAG72-chimeric antigen receptor (CAR) T cells in patients with epithelial ovarian cancer that is resistant to platinum-based therapy. This phase I trial aims to test the safety, side effects, and best dose of these modified immune cells designed to recognize and target a protein called TAG72 on tumor cells. The study also explores how these TAG72-specific T cells may help the immune system identify and attack cancer cells. Participants receive chemotherapy drugs fludarabine and cyclophosphamide intravenously from days -5 to -3, followed by an intraperitoneal infusion of TAG72-CAR T cells on day 0. The study uses a dose-escalation design to find the maximum tolerated dose and recommended dose for future research. Patients are monitored closely for safety and response after treatment. During the study, participants undergo multiple follow-up visits at 1, 7, 14, 21, 28, 60, and 90 days, then at 6, 9, and 12 months, with long-term monitoring up to 15 years. Researchers assess treatment safety by tracking dose-limiting toxicities and adverse events. They also measure how long the CAR T cells persist in the body, tumor response, progression-free survival, overall survival, and immune system activity through blood tests and tissue analysis.
CONDITIONS
Brief Title
Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to provide written informed consent
- Agreement to allow use of archival tissue from tumor biopsies or approval from study PI if unavailable
- Age over 18 years
- Performance status of 0 to 2 on ECOG scale or Karnofsky score of 70% or higher
- Documented platinum-resistant epithelial ovarian cancer with measurable disease
- Tumor cells expressing TAG72 protein in at least 1% of cells with positive intensity
- Prior treatment with and failure or intolerance to taxanes, liposomal doxorubicin, or other clinical benefit agents
- No known contraindications to leukapheresis, steroids, or tocilizumab
- Use of acceptable birth control during and for 3 months after treatment if of reproductive potential
- Absolute neutrophil count of at least 1,000/mm3
- Total serum bilirubin within specified limits, including Gilbert syndrome allowances
- Liver enzymes within specified limits depending on metastasis
- Coagulation tests within specified limits if not on therapeutic anticoagulation
- Creatinine clearance of at least 50 mL/min
- Cardiac function without acute abnormalities and left ventricular ejection fraction over 40%
- Negative QuantiFERON-TB Gold or equivalent test
You will not qualify if you...
- Not recovered from toxicities of prior therapy
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of allergic reactions to similar compounds
- Pneumonitis requiring steroids or current pneumonitis
- Signs or symptoms of bowel obstruction
- History of inflammatory bowel disease
- History of gastrointestinal perforation or symptomatic diverticular disease
- Recent intra-abdominal abscess within past 3 months
- Known peritoneal adhesions preventing intraperitoneal catheter placement
- Clinically significant or unstable arrhythmias within 2 weeks before consent
- History of optic neuritis or central nervous system inflammatory disease
- Known bleeding disorders
- Stroke or intracranial hemorrhage within 6 months before consent
- Other malignancies unless cured and no active disease for at least 3 years
- Uncontrolled active infection
- Active hepatitis B or C infection
- HIV infection
- Any other condition that may contraindicate participation due to safety concerns
- Receipt or planned receipt of certain therapies prior to leukapheresis or chemotherapy unless washout requirements met
- Inability to comply with all study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 3 days
Participants receive chemotherapy with fludarabine and cyclophosphamide intravenously before receiving the CAR T cells.
3 visits for chemotherapy administration
Duration - 1 day
Participants receive TAG72-CAR T cells administered intraperitoneally on the treatment day.
1 treatment visit (in-person)
Duration - Up to 15 years
Participants are followed for safety, response, and survival assessments after receiving CAR T cells.
Visits at 1, 7, 14, 21, 28, 60, 90 days, and 6, 9, 12 months, then long-term monitoring
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
L
Lorna Rodriguez
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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