Last reviewed · How we verify
NCT05700630
Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia
Phase 1 trial testing FT538 in HIV-1-infection. Withdrawn.
26 July 2024
Quick facts
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Start date | 15 July 2024 |
| Primary completion | 26 July 2024 |
| Estimated completion | 21 August 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- FT538 — full drug profile →
- Vorinostat (VORINOSTAT) — full drug profile →
Conditions studied
- HIV-1-infection — all drugs for HIV-1-infection →
- ART — all drugs for ART →
- Cd4+ Lymphocyte Deficiency — all drugs for Cd4+ Lymphocyte Deficiency →
- Lymphoid Tissue; Infection — all drugs for Lymphoid Tissue; Infection →
Sponsor
Masonic Cancer Center, University of Minnesota
Who can join
Adults 18 to 65, any sex, with HIV-1-infection or ART. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single center Phase I clinical trial of FT538 administered intravenously (IV) once every 14 days for 4 consecutive doses for the reduction of the HIV reservoir in lymphoid tissue of HIV-infected individuals receiving standard of care (SOC) antiretroviral therapy (ART). As this is an early 1st in human study and the 1st for HIV-infected individual, the safety of FT538 is confirmed prior to the addition of oral vorinostat to explore the concept of "Kick and Kill".
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Natural killer cells and their exosomes in viral infections and related therapeutic approaches: where are we?
Razizadeh MH, Zafarani A, Taghavi-Farahabadi M, Khorramdelazad H, et al · · 2023 · cited 17× · PMID 37749597 · DOI 10.1186/s12964-023-01266-2 -
Natural killer cell-related anti-tumour adoptive cell immunotherapy.
Qi Y, Li Y, Wang H, Wang A, et al · · 2024 · cited 5× · PMID 38837666 · DOI 10.1111/jcmm.18362 -
Advances in Induced Pluripotent Stem Cell-Derived Natural Killer Cell Therapy.
Qiao W, Dong P, Chen H, Zhang J. · · 2024 · cited 4× · PMID 39682724 · DOI 10.3390/cells13231976 -
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 -
Slow-Binding and Covalent HDAC Inhibition: A New Paradigm?
Raouf YS, Moreno-Yruela C. · · 2024 · cited 2× · PMID 39610753 · DOI 10.1021/jacsau.4c00828
Verify or expand the search:
- PubMed search for NCT05700630
- 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.
- NCT05708924 — MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer · Phase 1 · terminated
- 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 HIV-1-infection
Currently open trials in the same condition.
- NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
- NCT06919016 — A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1- · Phase 1 · active not recruiting
- NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV · Phase 2 · recruiting
- NCT06774872 — Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Succes · Phase 2 · recruiting
- NCT06890988 — Ending the Epidemic Interventions in the Dental Setting - UH3 · 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 NCT05700630 (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: 26 February 2024
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/NCT05700630.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing