NCT05762510 is a EARLY_PHASE1 clinical trial of GMCN-508B (LentiRed) in Transfusion Dependent Beta-Thalassemia, sponsored by First Affiliated Hospital of Guangxi Medical University.

Who is sponsoring NCT05762510?

NCT05762510 is sponsored by First Affiliated Hospital of Guangxi Medical University.

What drugs are being tested in NCT05762510?

Interventions in NCT05762510: GMCN-508B (LentiRed).

What condition does NCT05762510 study?

NCT05762510 studies Transfusion Dependent Beta-Thalassemia.

Is NCT05762510 still recruiting?

NCT05762510 is currently recruiting now. Last updated 9 May 2023.

Last reviewed 2023-05-09 · How we verify

NCT05762510

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

A Study Evaluating the Safety and Efficacy of LentiRed Drug Product in Transfusion-dependent β-Thalassemia [TDT]

Recruiting now EARLY_PHASE1 Last updated 9 May 2023

What this trial tests

EARLY_PHASE1 trial testing GMCN-508B (LentiRed) in Transfusion Dependent Beta-Thalassemia in 5 participants. Currently enrolling.

Timeline

22 February 2023

Primary endpoint
1 April 2028

31 October 2030

Quick facts

Lead sponsor	First Affiliated Hospital of Guangxi Medical University
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	22 February 2023
Primary completion	1 April 2028
Estimated completion	31 October 2030
Sites	1 location across China

Drugs / interventions tested

GMCN-508B (LentiRed)

Conditions studied

Transfusion Dependent Beta-Thalassemia — all drugs for Transfusion Dependent Beta-Thalassemia →

Sponsor

First Affiliated Hospital of Guangxi Medical University

Who can join

Adults 5 to 35, any sex, with Transfusion Dependent Beta-Thalassemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, open label, single-dose study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CD34+ Human Hematopoietic Stem Cells that was transduced with LentiRed Lentivrial vector.

Publications & conference data

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

Clinical hematopoietic stem cell-based gene therapy.
John T, Czechowicz A. · · 2025 · cited 6× · PMID 40285354 · DOI 10.1016/j.ymthe.2025.04.029
Advancements in Hematopoietic Stem Cell Gene Therapy: A Journey of Progress for Viral Transduction.
Giommetti A, Papanikolaou E. · · 2024 · cited 6× · PMID 38920667 · DOI 10.3390/cells13121039
Current and future treatments for sickle cell disease: From hematopoietic stem cell transplantation to in vivo gene therapy.
Ball J, Bradley A, Le A, Tisdale JF, et al · · 2025 · cited 5× · PMID 40083162 · DOI 10.1016/j.ymthe.2025.03.016
Towards a Cure for Diamond-Blackfan Anemia: Views on Gene Therapy.
Vale M, Prochazka J, Sedlacek R. · · 2024 · cited 2× · PMID 38891052 · DOI 10.3390/cells13110920
Gene therapy for hemoglobinopathies: Clinical trial results and biology of hematopoietic stem cell and the bone marrow niche.
Aprile A, Lidonnici MR, Ferrari G. · · 2025 · PMID 41253147 · DOI 10.1016/j.xcrm.2025.102419

Verify or expand the search:

Other First Affiliated Hospital of Guangxi Medical University trials

Trials by the same sponsor.

NCT07459296 — Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC · Phase 3 · recruiting
NCT07342322 — A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Spatial · Phase 2 · not yet recruiting
NCT07338357 — Clinical Study of CLL-1 CAR-T in the Treatment of Children With R/R AML · EARLY_PHASE1 · not yet recruiting
NCT07132008 — Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer · Phase 3 · not yet recruiting
NCT07074444 — Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel · Phase 4 · 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 NCT05762510 (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 First Affiliated Hospital of Guangxi Medical University
Last refreshed: 9 May 2023

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/NCT05762510.

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