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

NCT05708924 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 2021LS103P01CA111412
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Solid Tumor; Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Response Rate (ORR)

  72 months

• Determine Progression-free Survival (PFS)

  72 months

• Adverse Events

  72 months

Other Outcomes (1)

• Tumor Biopsies (if Feasible) at the Time of Catheter Placement and Catheter Removal for Study Related Analysis

  72 months

Study Arms (2)

IP FT538 monotherapy

EXPERIMENTAL

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

IP FT538 + Enoblituzumab

EXPERIMENTAL

Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab

Drug: FT538; Biological: Enoblituzumab

Interventions

FT538 DRUG

FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.

IP FT538 + Enoblituzumab; IP FT538 monotherapy

Enoblituzumab BIOLOGICAL

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

Also known as: RES242, MGA271

IP FT538 + Enoblituzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Masonic Cancer Center - University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Results Point of Contact

• Title: Dr. Melissa Geller
• Organization: Masonic Cancer Center

gelle005@umn.edu

612-626-3111

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: February 1, 2023
• Study Start: April 28, 2023
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)