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

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

NCT ID: NCT05708924

Condition: Cancer
Solid Tumor
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer

Conditions: Official terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Suspended

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: FT538
Description: FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.
Arm group label: IP FT538 + Enoblituzumab
Arm group label: IP FT538 monotherapy

Intervention type: Biological
Intervention name: Enoblituzumab
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
Arm group label: IP FT538 + Enoblituzumab

Other name: RES242

Other name: MGA271

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Masonic Cancer Center - University of Minnesota

Address:
City: Minneapolis
Zip: 55455
Country: United States

Start date: April 28, 2023

Completion date: September 30, 2028

Lead sponsor:
Agency: Masonic Cancer Center, University of Minnesota
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Masonic Cancer Center, University of Minnesota

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05708924