Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treati… (NCT03735589) | Clinical Trial Compass
WithdrawnPhase 1/2
Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Stopped: new study to be created
United States0Started 2023-12-15
Plain-language summary
This phase I/IIa trial studies the side effects and best dose of a type of specialized immune cell (natural killer cell-like cytotoxic T-lymphocytes (CTLs) (nCTLs) and how well they work when given with a vaccine (alpha-type-1 polarized dendritic cells) in treating patients with stage II-IV ovarian, fallopian tube, or primary peritoneal cancer. nCTLs are immune cells that are isolated from each patient?s blood and "taught" in the laboratory how to recognize and eliminate tumor cells. These "educated" immune cells are then given back to the patient. An alpha-type-1 polarized dendritic cell vaccine is another population of "educated" immune cells that work to support the infused nCTLs. Giving nCTLS with a dendritic cell vaccine may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
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:
* Eligible patients will be women with stages II-IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with no radiologic evidence of disease (NED) or minimal disease burden after 1st line therapy. These patients would normally enter a period of observation after standard management.
* Life expectancy \> 6 months.
* Have been informed of other treatment options.
* Patients must be reasonable candidates for intraperitoneal (IP) port placement with no prior evidence of persistent abdominal wall or intraperitoneal infections, renal toxicity, or bowel obstruction or fistula.
* Patients must have documented available tumor: at least 1 cm of bulk tumor mass collected at the time of primary or interval debulking surgery. The specimen may be obtained on this protocol or as part of other Institutional Review Board (IRB) approved tumor banking protocols.
* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\]).
* Must have adequate venous access for apheresis. (Pheresis catheter placement for cell collection is allowed).
* Patient must agree to leukapheresis.
* Patients must agree to appropriate clinical monitoring to receive the study regimens.
* Absolute neutrophil count (ANC) greater than or equal to 1,000/uL.
* Platelets greater than or equal to 75,000/uL.
* Hemoglobin greater than or equal to 8.0 g/dL.
* Creatinine less than or equal to 2 x institutional upper lim…
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.
What they're measuring
1
Incidence of adverse events as assessed by Cancer Therapy Evaluation Program (CTEP) version 4 of the Common Terminology Criteria for Adverse Events (CTCAE)
Timeframe: Up to 12 months
2
Dose-limiting toxicities (DLT) assessed by CTCAE version 5
Timeframe: Up to 14 days after intraperitoneal (IP) infusion of nCTLs
3
Change in immune response
Timeframe: From baseline (day 0) to day 2 (48 hours after adoptive cell therapy [ACT]) administration
4
Persistence of nCTLs after their adoptive transfer