Clinical trial NCT05708924: MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Official title: MT2021-27 Intraperitoneal FT538 With Intravenous Enoblituzumab in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Solid Tumor
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To determine the maximum tolerated dose (MTD) of FT538 monotherapy when administered via intraperitoneal (IP) catheter and in combination with intravenous (IV) enoblituzumab in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.


Eligibility criteria: 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).
* Platinum Resistant: may receive FT538 as 2nd line (as 1st salvage therapy).
* At least 18 years of age at the time of consent.
* GOG Performance Status 0, 1, or 2 (refer to Appendix I).
* Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu or enoblituzumab) start
* Pulmonary Function: Oxygen saturation ≥ 90% on room air; PFTs are performed only if known history or as medically indicated - if done, must have pulmonary function \>50% corrected DLCO and FEV1.
* Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI; no clinically significant cardiovascular disease including any of the following: stroke or myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher (Appendix I).

Exclusion Criteria:

* Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months.
* Currently receiving or likely to require systemic immunosuppressive therapy
* 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 FT538
* Live vaccine within 6 weeks prior to start of lympho-conditioning.
* Known allergy to the following FT538 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.

Primary outcomes:
measure: Determine Maximum Tolerated Dose (MTD) of FT538
timeFrame: 48 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 72 months
measure: Determine progression-free survival (PFS)
timeFrame: 72 months
measure: Adverse Events
timeFrame: 72 months
Other outcomes:
measure: Tumor biopsies (if feasible) at the time of catheter placement and catheter removal for study related analysis
timeFrame: 72 months
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center - University of Minnesota
state: Minnesota
Study officials:
References: