MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT05708924|
Recruitment Status : Not yet recruiting
First Posted : February 1, 2023
Last Update Posted : February 24, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Cancer Solid Tumor Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer||Drug: FT538 Biological: Enoblituzumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||MT2021-27 Intraperitoneal FT538 With Intravenous Enoblituzumab in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer|
|Estimated Study Start Date :||May 30, 2023|
|Estimated Primary Completion Date :||September 30, 2026|
|Estimated Study Completion Date :||September 30, 2028|
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
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
FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.
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
- Determine Maximum Tolerated Dose (MTD) of FT538 [ Time Frame: 48 months ]
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.
- Overall Response Rate (ORR) [ Time Frame: 72 months ]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) [ Time Frame: 72 months ]Number of participants experiencing progression free survival at one year follow up
- Adverse Events [ Time Frame: 72 months ]Number of participants experiencing adverse events with the combination of Enoblituzumab and FT538
- Tumor biopsies (if feasible) at the time of catheter placement and catheter removal for study related analysis [ Time Frame: 72 months ]Tumors will be biopsied to assess tumor microenvironment.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05708924
|Contact: Melissa Gellerfirstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center - University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Responsible Party:||Masonic Cancer Center, University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||February 1, 2023 Key Record Dates|
|Last Update Posted:||February 24, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Fallopian Tube Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Fallopian Tube Diseases
Digestive System Neoplasms
Digestive System Diseases