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CAR T-cell Therapy
CAR T-Cell Therapy for Ovarian Cancer
Phase 1
Recruiting
Led By Lorna Rodriguez
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented TAG72+ (> 1% cells >= +1 intensity) tumor expression by IHC (MAb CC49) as evaluated by COH Pathology Core
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 must be determined radiographically. Participant must have at least 1 measurable lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post treatment
Awards & highlights
Study Summary
This trial tests a new cancer treatment using the patient's own T cells. The T cells are modified to better recognize and kill cancer cells.
Who is the study for?
This trial is for adults over 18 with ovarian cancer that didn't respond to platinum therapy. They must have a certain level of physical fitness, no severe allergies to study drugs, and agree to use birth control. People can't join if they haven't recovered from previous treatments' side effects, have significant heart rhythm problems, active autoimmune diseases requiring steroids or other immunosuppressants, uncontrolled infections including hepatitis B/C or HIV, bleeding disorders on anticoagulants, recent strokes or brain hemorrhages.Check my eligibility
What is being tested?
The trial tests TAG72-CAR T cells in patients with resistant epithelial ovarian cancer. Patients' own T cells are modified to target TAG72 protein on tumor cells. The safety and optimal dose of these engineered T cells will be evaluated alongside standard therapies like Fludarabine and Cyclophosphamide.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and fatigue; organ inflammation; infusion-related reactions; blood cell count changes leading to increased infection risk; potential worsening of underlying autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor shows positive for TAG72 based on a specific test.
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My ovarian cancer did not respond well to platinum therapy and has worsened.
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I am 18 years old or older.
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I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.
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I am mostly able to care for myself and remain up and about.
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I can understand and am willing to sign the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Expansion of CAR T cells
Overall survival (OS)
Persistence of CAR T cells
+3 moreOther outcome measures
CAR immunogenicity
Circulating cell-free deoxyribonucleic acid in peripheral blood
Gene expression
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TAG72-CAR T cells)Experimental Treatment3 Interventions
Patients receive fludarabine IV and cyclophosphamide IV on days -5 to -3. Patients receive TAG72-CAR T cells IP on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,427 Total Patients Enrolled
7 Trials studying Ovarian Cancer
217 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,615 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Lorna RodriguezPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bilirubin levels are within the required range.Your liver enzyme levels are not more than 5 times the upper limit of normal. This will be checked within 42 days before you agree to join the study.I am on medication to suppress my immune system due to an autoimmune disease.I am currently experiencing symptoms of a blocked intestine.I have had a gastrointestinal perforation or symptomatic diverticular disease.My surgeon believes I can't have a catheter placed due to internal scar tissue.My tumor shows positive for TAG72 based on a specific test.I am still experiencing side effects from my previous cancer treatment.My heart rhythm problem is not stable even with medication.My ovarian cancer did not respond well to platinum therapy and has worsened.I have a history of optic neuritis or other immune-related brain diseases.I have severe ascites but can still be considered for the trial on a case-by-case basis.I am 18 years old or older.You have had allergic reactions to similar drugs or substances in the past.Your blood test for aspartate aminotransferase (AST) should not be more than 5 times the normal level.I have a history of inflammatory bowel disease.I have an active hepatitis B or C infection.My heart rhythm problem is not stable even with medication.I do not have any ongoing infections that aren't under control.I have not had a stroke or brain bleed in the last 6 months.If you are not taking blood thinners, your blood clotting test results should be within a certain range.I have been cancer-free for over 3 years, except for minor skin cancers.I am HIV positive.I have a bleeding disorder or am on blood thinners.Your kidneys are working well, with a clearance rate of at least 50 mL/min, as measured by a test within 42 days of agreeing to participate.My recent heart test shows no serious issues needing further checks or treatment.I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.I have not had an intra-abdominal abscess in the last 3 months.I have tried treatments like platinum, taxanes, or doxorubicin for my condition without success or could not tolerate them.Your heart's pumping ability is above 40%, as measured within 42 days of agreeing to join the study.I am mostly able to care for myself and remain up and about.I can understand and am willing to sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TAG72-CAR T cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current capacity of participants accepted for this trial?
"Affirmative. According to information published on clinicaltrials.gov, this medical trial is actively recruiting potential participants and has been since its posting date of May 5th 2022. As of the most recent update in July 21st 2022, 33 patients are sought from a single site."
Answered by AI
What are the objectives of this research project?
"This clinical trial will assess the incidence of dose-limiting toxicities (DLTs) over a 1 year period, while also assessing secondary metrics such as CAR T cell persistence, expansion and progression-free survival. Quantitative rates with 90% Clopper and Pearson binomial confidence intervals shall be established to evaluate these outcomes."
Answered by AI
To what extent are Chimeric Antigen Receptor T-cells hazardous to patients?
"Chimeric Antigen Receptor T-cells have been scored a 1 due to limited data surrounding their efficacy and safety. This is because it's currently in its first phase of clinical trials."
Answered by AI
Are there still opportunities for individuals to enroll in this experiment?
"According to the clinicaltrials.gov database, this investigation is in search of participants and was published on May 5th 2022 with its latest update occurring July 21st 2022."
Answered by AI
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