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New treatment option for Platinum-Resistant Ovarian Carcinoma
Official title Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer
ClinicalTrials.gov ID: NCT05225363
What this study is testing
What is Chimeric Antigen Receptor T-cells?
Chimeric Antigen Receptor T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for platinum-resistant ovarian carcinoma.
Also referred to as CAR T Cell, CAR T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- ELIGIBILITY CRITERIA 1.1 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...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- ELIGIBILITY CRITERIA 1.1 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.