CancerPhase 1NCT05708924
MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
A Phase 1 study testing FT538 and Enoblituzumab in people with Cancer and Solid Tumor, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Ovarian Cancer
- What is being tested?
- FT538 and Enoblituzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2023to 6 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center - University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
- Conditions
- Cancer, Solid Tumor, Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- FT538, Enoblituzumab
- Medical subject headings
- Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT538Drug
FT538 IP at assigned dose level on Day 1, Day 8, and Day 15.
EnoblituzumabBiological
Also called RES242, MGA271
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: FT538; Biological: Enoblituzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Secondary outcomes (3)
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.
Measured: 72 months
Determine Progression-free Survival (PFS)
Number of participants experiencing progression free survival at one year follow up
Measured: 72 months
Adverse Events
Number of participants experiencing adverse events with the combination of Enoblituzumab and FT538
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start28 Apr 2023
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Why it stopped: Product withdrawn from clinical development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708924
- Sponsor's protocol ID
- 2021LS103
- Other IDs
- P01CA111412
- Status last verified
- Jul 2025
- First submitted
- 14 Dec 2022
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT2021-27 Intraperitoneal FT538 With Intravenous Enoblituzumab in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT05708924
- Acronym / sponsor ID
- 2021LS103
- Conditions
- Cancer, Solid Tumor, Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product withdrawn from clinical development
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP FT538 monotherapy | Experimental | Drug: FT538Level -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 |
| IP FT538 + Enoblituzumab | Experimental | Drug: FT538, Biological: EnoblituzumabLevel 5: IP FT538 at the safe dose (MTD-1) + Enoblituzumab Level 6: IP FT538 at the highest dose (MTD) + Enoblituzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT538FT538 IP at assigned dose level on Day 1, Day 8, and Day 15. | Drug | IP FT538 + Enoblituzumab, IP FT538 monotherapy |
| EnoblituzumabAlso: RES242, MGA271Enoblituzumab 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 | Biological | IP FT538 + Enoblituzumab |
Primary outcome
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.
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: 72 months
Determine Progression-free Survival (PFS)
Time frame: 72 months
Adverse Events
Time frame: 72 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT538 and Enoblituzumab in people with Cancer and Solid Tumor, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Maximum Tolerated Dose (MTD) of FT538 (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.