Is NCT05225363 recruiting in Duarte, CA?

Yes, NCT05225363 is currently recruiting participants at its Duarte, CA location. This platinum-resistant ovarian carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Platinum-Resistant Ovarian Carcinoma Clinical Trial in Duarte, CA

Q: How do I join the platinum-resistant ovarian carcinoma clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Platinum-Resistant Ovarian Carcinoma Study in Duarte

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.

Sponsor: City of Hope Medical Center

Who Can Participate

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\

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT05225363) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Platinum-Resistant Ovarian Carcinoma Treatment Options in Duarte, CA

If you're searching for platinum-resistant ovarian carcinoma treatment options in Duarte, CA, this clinical trial (NCT05225363) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced platinum-resistant ovarian carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all platinum-resistant ovarian carcinoma clinical trials near you to find additional studies recruiting in your area.

Platinum-Resistant Ovarian Carcinoma Clinical Trial in Duarte, CA

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