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

Primary Purpose

Cancer, Solid Tumor, Ovarian Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FT538
Enoblituzumab
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Masonic Cancer Center - University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IP FT538 monotherapy

IP FT538 + Enoblituzumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Determine progression-free survival (PFS)
Number of participants experiencing progression free survival at one year follow up
Adverse Events
Number of participants experiencing adverse events with the combination of Enoblituzumab and FT538

Full Information

First Posted
December 14, 2022
Last Updated
May 1, 2023
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05708924
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Solid Tumor, Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IP FT538 monotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
IP FT538 + Enoblituzumab
Arm Type
Experimental
Arm Description
Level 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab
Intervention Type
Drug
Intervention Name(s)
FT538
Intervention Description
FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.
Intervention Type
Biological
Intervention Name(s)
Enoblituzumab
Other Intervention Name(s)
RES242, MGA271
Intervention Description
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
Primary Outcome Measure Information:
Title
Determine Maximum Tolerated Dose (MTD) of FT538
Description
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.
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
72 months
Title
Determine progression-free survival (PFS)
Description
Number of participants experiencing progression free survival at one year follow up
Time Frame
72 months
Title
Adverse Events
Description
Number of participants experiencing adverse events with the combination of Enoblituzumab and FT538
Time Frame
72 months
Other Pre-specified Outcome Measures:
Title
Tumor biopsies (if feasible) at the time of catheter placement and catheter removal for study related analysis
Description
Tumors will be biopsied to assess tumor microenvironment.
Time Frame
72 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Geller
Phone
612-626-3111
Email
gelle005@umn.edu
Facility Information:
Facility Name
Masonic Cancer Center - University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Geller, MD
Phone
612-626-3111
Email
gelle005@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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