Last reviewed · How we verify
NCT05708924
MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Phase 1 trial testing FT538 in Cancer in 1 participant. Terminated before completion.
6 August 2024
Quick facts
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 28 April 2023 |
| Primary completion | 6 August 2024 |
| Estimated completion | 6 August 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- FT538 — full drug profile →
- Enoblituzumab — full drug profile →
Conditions studied
- Cancer — all drugs for Cancer →
- Solid Tumor — all drugs for Solid Tumor →
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Peritoneal Cancer — all drugs for Peritoneal Cancer →
Sponsor
Masonic Cancer Center, University of Minnesota
Who can join
18 and older, any sex, with Cancer or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (8 terms — click to expand)
| Reaction | System | IP FT538 Monotherapy | IP FT538 + Enoblituzumab |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Hypercalcemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Buttock pain | Musculoskeletal and connective tissue disorders | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
Data from ClinicalTrials.gov NCT05708924 adverse events section.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tumor Immunotherapy Targeting B7-H3: From Mechanisms to Clinical Applications.
Guo Y, Wang X, Zhang C, Chen W, et al · · 2025 · cited 16× · PMID 40171330 · DOI 10.2147/itt.s507522 -
Pluripotent stem cell-based immunotherapy: advances in translational research, cell differentiation, and gene modifications.
Lei Q, Deng H, Sun S. · · 2025 · cited 3× · PMID 40110110 · DOI 10.1093/lifemedi/lnaf002 -
Challenges and opportunities of human iPSC-derived NK as "Off-the-shelf" cellular therapies.
Romanini N, Netsrithong R, Themeli M, Tazzari M. · · 2025 · PMID 41462483 · DOI 10.1186/s13046-025-03558-6
Verify or expand the search:
- PubMed search for NCT05708924
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of FT538
Trials testing the same drug.
- NCT05700630 — Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia · Phase 1 · withdrawn
- NCT04714372 — FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia · Phase 1 · completed
- NCT05069935 — FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors · Phase 1 · terminated
- NCT04614636 — FT538 in Subjects With Advanced Hematologic Malignancies · Phase 1 · terminated
Other recruiting trials for Cancer
Currently open trials in the same condition.
- NCT07390045 — Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors · NA · recruiting
- NCT07528547 — Hypersight and Ethos In Pediatric Radiotherapy · NA · recruiting
- NCT07481890 — Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients. · NA · recruiting
- NCT07402057 — Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations · NA · recruiting
- NCT07305740 — On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety · NA · recruiting
Other Masonic Cancer Center, University of Minnesota trials
Trials by the same sponsor.
- NCT06772090 — Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies · NA · not yet recruiting
- NCT06584929 — Rural Smoking Cessation · NA · not yet recruiting
- NCT07153016 — LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorect · NA · recruiting
- NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL · Phase 2 · recruiting
- NCT07070726 — UNTOLD Ovarian Cancer Unmet Needs Survey · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05708924 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota
- Last refreshed: 14 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05708924.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing