NCT03666871 (TRAILBLAZER) is a Phase 1, PHASE2 clinical trial of SB-728-T in HIV Infections, sponsored by University of Cincinnati.

Who is sponsoring NCT03666871?

NCT03666871 is sponsored by University of Cincinnati.

What drugs are being tested in NCT03666871?

Interventions in NCT03666871: SB-728-T, Expanded unmodified autologous CD4+ T cells.

What condition does NCT03666871 study?

NCT03666871 studies HIV Infections.

Is NCT03666871 still recruiting?

NCT03666871 is currently completed. Last updated 21 May 2024.

Last reviewed 2024-05-21 · How we verify

NCT03666871: TRAILBLAZER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CCR5-modified CD4+ T Cells for HIV Infection

Completed Phase 1, PHASE2 Last updated 21 May 2024

What this trial tests

Phase 1, PHASE2 trial testing SB-728-T in HIV Infections in 30 participants. Completed in 28 February 2024.

Timeline

12 June 2019

Primary endpoint
31 January 2024

28 February 2024

Quick facts

Lead sponsor	University of Cincinnati
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	12 June 2019
Primary completion	31 January 2024
Estimated completion	28 February 2024
Sites	1 location across United States

Drugs / interventions tested

SB-728-T — full drug profile →
Expanded unmodified autologous CD4+ T cells — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

University of Cincinnati

Who can join

Adults 18 to 70, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Comparative Study of Autologous CD4+ T Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 versus ex vivo Expanded Unmodified Autologous CD4+ T Cells in Treated HIV-1 Infected Subjects

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Applications of genome editing technology in the targeted therapy of human diseases: mechanisms, advances and prospects.
Li H, Yang Y, Hong W, Huang M, et al · · 2020 · cited 733× · PMID 32296011 · DOI 10.1038/s41392-019-0089-y
Gene editing and CRISPR in the clinic: current and future perspectives.
Hirakawa MP, Krishnakumar R, Timlin JA, Carney JP, et al · · 2020 · cited 126× · PMID 32207531 · DOI 10.1042/bsr20200127
Ready for Repair? Gene Editing Enters the Clinic for the Treatment of Human Disease.
Ernst MPT, Broeders M, Herrero-Hernandez P, Oussoren E, et al · · 2020 · cited 67× · PMID 32775490 · DOI 10.1016/j.omtm.2020.06.022
The clinical potential of gene editing as a tool to engineer cell-based therapeutics.
Ashmore-Harris C, Fruhwirth GO. · · 2020 · cited 50× · PMID 32034584 · DOI 10.1186/s40169-020-0268-z
CRISPR-Cas9 Mediated Exonic Disruption for HIV-1 Elimination.
Herskovitz J, Hasan M, Patel M, Blomberg WR, et al · · 2021 · cited 40× · PMID 34774454 · DOI 10.1016/j.ebiom.2021.103678
The comparison of ZFNs, TALENs, and SpCas9 by GUIDE-seq in HPV-targeted gene therapy.
Cui Z, Liu H, Zhang H, Huang Z, et al · · 2021 · cited 33× · PMID 34938601 · DOI 10.1016/j.omtn.2021.08.008
From fiction to science: clinical potentials and regulatory considerations of gene editing.
Schacker M, Seimetz D. · · 2019 · cited 23× · PMID 31637541 · DOI 10.1186/s40169-019-0244-7
The chemokine receptor CCR5: multi-faceted hook for HIV-1.
Faivre N, Verollet C, Dumas F. · · 2024 · cited 19× · PMID 38263120 · DOI 10.1186/s12977-024-00634-1

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other University of Cincinnati trials

Trials by the same sponsor.

NCT05605366 — Minocycline In Neurocognitive Outcomes - Sickle Cell Disease · Phase 1 · not yet recruiting
NCT07528638 — Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND) · NA · not yet recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment · NA · recruiting
NCT07447895 — Early Pelvic Floor Physical Therapy for Women Undergoing Pelvic Radiation for Gynecologic Malignancies · NA · not yet recruiting
NCT07231588 — Oral 5 Strain Probiotic for GI Toxicity Mitigation During Pelvic Radiation · EARLY_PHASE1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03666871 (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 University of Cincinnati
Last refreshed: 21 May 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/NCT03666871.

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