MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

MT2021-27 Intraperitoneal FT538 With Intravenous Enoblituzumab in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Ovarian Cancer; Fallopian Tube Cancer; Solid Tumor; Peritoneal Cancer
• Intervention / Treatment: Drug: FT538; Biological: Enoblituzumab

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center - University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IP FT538 monotherapy; Level -1: IP FT538 monotherapy 5 x 10^7 cells/dose Level 1: IP FT538 monotherapy 1 x 10^8 cells/dose Level 2: IP FT538 monotherapy 3 x 10^8 cells/dose Level 3: IP FT538 monotherapy 1 x 10^9 cells/dose Level 4: IP FT538 monotherapy 1.5 x 10^9 cells/dose	Drug: FT538; FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.
Experimental: IP FT538 + Enoblituzumab; Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab	Drug: FT538; FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.; Biological: Enoblituzumab; Enoblituzumab 15 mg/kg IV begin on Day -6 and continuing once every 3 weeks beginning on Day 22 until disease progression or unacceptable toxicity - refer to Section 7.2.1 for timing of the enoblituzumab dose on Day 22 if steroid pre-meds are needed due to an infusion reaction with the 1st enoblituzumab dose as there is a 14 day ban on corticosteroid use after the last dose of FT538; Other Names: MGA271; RES242

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine Maximum Tolerated Dose (MTD) of FT538	The primary objective of the study is 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. Monitor the patient for signs of acute infusion related reaction during and after IP infusion. For IV infusion signs of a possible reaction are rigors and chills, rash, urticaria, hypotension, dyspnea, and angioedema.	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Overall response rate is defined as number of patients who have a partial or complete response to therapy divided by the total number of patients who received treatment.	72 months
Adverse Events	Number of participants experiencing adverse events with the combination of Enoblituzumab and FT538	72 months
Determine Progression-free Survival (PFS)	Number of participants experiencing progression free survival at one year follow up	72 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Biopsies (if Feasible) at the Time of Catheter Placement and Catheter Removal for Study Related Analysis	Tumors will be biopsied to assess tumor microenvironment.	72 months

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): August 6, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Genital Diseases, Female; Adnexal Diseases; Genital Neoplasms, Female; Peritoneal Diseases; Abdominal Neoplasms; Fallopian Tube Diseases; Peritoneal Neoplasms; Fallopian Tube Neoplasms
• Other Study ID Numbers: 2021LS103; P01CA111412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No