Immune cells retrained to hunt ovarian cancer in new trial
NCT ID NCT05225363
First seen Jul 01, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This phase 1 trial investigates a new treatment for advanced ovarian cancer that has stopped responding to platinum chemotherapy. The therapy uses a patient's own immune cells, called T cells, which are genetically modified in a lab to recognize and attack a protein called TAG72 found on cancer cells. The study aims to determine the safest dose and evaluate side effects in up to 33 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TAG72-CAR T cells
- What this could lead to
- If successful, this approach could offer a new treatment option for patients with platinum-resistant ovarian cancer by harnessing the immune system to target cancer cells.
- What could go wrong
- This is an early phase 1 trial focused on safety and dosing, so it is not yet known if the treatment will be effective. There are risks of side effects from the CAR T cells and the chemotherapy used in the regimen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
ELIGIBILITY CRITERIA 1.1 Inclusion Criteria * 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\* 1.2 Exclusion Criteria * 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. o Massive ascites requiring therapeutic paracentesis will not be cause for ineligibility, per se, but will be evaluated on an individual basis. Investigators who have questions regarding assessing ascites are asked to speak with the Principal Investigator. * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug combo aims to shrink Hard-to-Treat pancreatic and ovarian tumors
- Engineered immune cells take aim at Hard-to-Treat cancers
- New hope for Platinum-Resistant ovarian cancer: ONC201 and paclitaxel combo trial launches
- Heated chemo during surgery may fight ovarian cancer return
- New drug cocktail targets Hard-to-Treat ovarian and endometrial cancers
- New hope for Platinum-Resistant ovarian cancer: PLX038 trial launches