Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Plat… (NCT03907527) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
United States71 participantsStarted 2019-04-30
Plain-language summary
This is a Phase I/Ib dose escalation, dose expansion, study to evaluate the safety and identify the recommended dose of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc.) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that have progressed after receiving standard of care therapies or are not eligible to receive available therapies with known clinical benefit will be eligible for the study. Patients must have measurable disease that can be accurately measured by RECIST 1.1 criteria in at least one dimension as \>= 1.0 cm or \> 1.5 cm lymph node with computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI) techniques.
* Platinum resistant is defined as progression of disease within six months of platinum regimen.
* Patients with BRCA mutations who have completed standard therapies (including PARP inhibitors) are allowed on this study.
* Patients must be capable of understanding and providing a written informed consent.
* Patients must be 14 days from previous cytotoxic chemotherapy at time of cell collection.
* Laboratory values must indicate adequate organ function.
* Patients must be at least 28 days post systemic steroids prior to enrollment except as premedication for contrast allergy and/or other protocol-mandated medication.
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 2.
* Patients must have recovered from major acute infections and/or recent surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.