TAG72-CAR T Cells for Platinum-Resistant Ovarian Cancer
This study is testing a new treatment called TAG72-CAR T cells for women with epithelial ovarian cancer that has not responded to platinum-based chemotherapy. T cells are immune cells that fight infections. In this study, your own T cells will be collected and modified in a lab to recognize a protein called TAG72, which is found on cancer cells. These modified T cells are given back to you, along with cyclophosphamide and fludarabine, to help your immune system find and destroy cancer cells. Researchers want to see how safe this treatment is, what side effects it might cause, and to find the best dose. The study plans to enroll 33 women who are at least 18 years old and meet other health criteria. We will also look at how well the treatment works to shrink tumors and how long the modified T cells stay in your body.
- Study design
- This is an interventional study with a planned enrollment of 33 participants. It is designed to evaluate the safety and tolerability of TAG72-CAR T cells.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for adverse events for up to 1 year after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05225363
Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~33 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Chimeric Antigen Receptor T-cellsCyclophosphamideFludarabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs)
Measured over Up to 28 days
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Lorna Rodriguez · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participant must have the ability to understand and the willingness to sign a written informed consent.
Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with Study PI approval.
Age \> 18 years.
ECOG Performance status 0 - 2 or KPS ≥70%.
Documented platinum resistant EOC (defined as disease that has progressed within six months of completing platinum therapy, or lack of response or disease progression while receiving the most recent platinum-based therapy, respectively). Progression may be determined radiographically (not RECIST) or by new onset of malignant pleural effusion. Participant may have at least 1 measurable lesion or disease measured by PCI at the time of surgery.
Documented TAG72+ (\> 1% cells ≥ +1 intensity) tumor expression by IHC (MAb CC49) as evaluated by COH Pathology Core.
In addition to platinum agents, participant must have received and failed, or have been intolerant to taxanes, liposomal doxorubicin or other agents known to confer clinical benefit. Participants are not required to fail all of these chemotherapy agents if, in the investigator's opinion, they would benefit from treatment on the current protocol.
No known contraindications to leukapheresis, steroids or tocilizumab.
Participant of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment.
\_ANC ≥ 1,000/mm3
Total serum bilirubin ≤ 1.5 x ULN Patients with Gilbert syndrome may be included if their total bilirubin is \< 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.
AST \< 3 x ULN if liver metastasis: AST \< 5 x ULN)
ALT \< 3 x ULN if liver metastasis: ALT \< 5 x ULN)
Participants not receiving therapeutic anticoagulation: INR or aPTT ≤1.5 x ULN
Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
Cardiac function (12 lead-ECG) without acute abnormalities requiring investigation or intervention
Left ventricular ejection fraction \>40%
QuantiFERON-TB Gold or equivalent\*
Exclusion
Participant has not yet recovered from toxicities of prior therapy.
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study.
History of (non-infectious or COVID-related) pneumonitis that required steroids or current pneumonitis
Current signs and/or symptoms of bowel obstruction
History of inflammatory bowel disease
History of gastrointestinal perforation or symptomatic diverticular disease
History of intra-abdominal abscess within the past 3 months.
Patients with known peritoneal adhesions that preclude the placement of an intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal catheter.
Participant with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the 'Screening/Leukapheresis/Treatment' consent.
Participant with known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder.
Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).
History of stroke or intracranial hemorrhage within 6 months prior to signing the 'Screening/Leukapheresis/Treatment' consent.
History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent with no known active disease present for ≥ 3 years, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin.
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
HIV infection.
Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.
Subject has received or plans to receive the following therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy, unless stopped according to the washout requirements:
Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
What this trial measures
- Incidence of dose limiting toxicities (DLTs)Up to 28 days
Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
- Incidence of adverse eventsUp to 1 year post treatment
Adverse Events are graded using NCI CTCAE v.5.