Experimental cell therapy targets Hard-to-Treat ovarian cancers
NCT ID NCT06342986
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new immune cell therapy called FT536 for people with recurrent ovarian, fallopian tube, or primary peritoneal cancer. The treatment is given directly into the abdomen after a short course of chemotherapy. Only 3 participants are enrolled, so the main goal is to check safety and see if the therapy can slow cancer growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FT536 (a type of immune cell therapy made from stem cells, given into the abdomen)
- What this could lead to
- If it works, this could point toward a new treatment option for people with recurrent gynecologic cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early, small Phase 1 trial with only 3 participants, so it is too soon to know if it is safe or effective. The treatment also requires chemotherapy beforehand, which has its own side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
3 people
The number who actually took part.
- Started
-
Jul 2024
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirements (no limit to the maximum number of prior treatments). * Must have received prior bevacizumab. * In the presence of a BRCA mutation, must have received a prior PARP inhibitor. * Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu) start * Agrees to the placement of an intraperitoneal catheter before the 1st dose of study directed drug (chemotherapy) and remains in place through Day 36 or longer if retreatment is planned. Refer to Section 6.4 if catheter cannot be successfully placed. * Agrees to undergo a tumor biopsy if feasible at the time the catheter is placed and removed - Accessible tumor for biopsy is not required for eligibility * Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077) to fulfill the FDA recommended 15 years of followup for a genetically modified cell product. Exclusion Criteria: * Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months. If of childbearing potential (have a uterus and ovaries) and engaged in heterosexual intercourse, must have a negative pregnancy test (serum or urine) within 14 days before the 1st CY/Flu. Patient must agree to use highly effective method of birth control from the screening visit until at least 12 months after the final dose of CY, or at least 4 months after the final dose of FT536, whichever is longer. * Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone \>5 mg daily) for any reason from Day -5 to 14 days after the last FT536 infusion) with the exception of corticosteroids as a pre-medication per institutional standard of care - topical and inhaled steroids are permitted. * Active autoimmune disease requiring systemic immunosuppressive therapy. * History of severe asthma and currently on chronic systemic medications. * Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy. * Receipt of any biological therapy, chemotherapy, or radiation therapy (except palliative RT), within 2 weeks prior to the first dose of FT536 or five half-lives, whichever is shorter; or any investigational agent within 28 days prior to the first dose of FT536. * Live vaccine within 6 weeks prior to start of lympho-conditioning. * Known allergy to the following FT536 components: albumin (human) or dimethyl sulfoxide (DMSO). * Prior enoblituzumab. * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment. (Refer to Section 5.1.8 regarding history of brain metastases.) * Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic viral hepatitis is allowed. * Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to patient. * Any medical condition or clinical laboratory abnormality that, per investigator judgement, precludes safe participation in and completion of the study or that could affect compliance with protocol conduct or interpretation of results.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Fallopian tube cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer