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NCT06655662
Evaluating Safety and Efficacy of Lentiviral-transduced CD34+ HSCs in Β-thalassaemia Patients.
Phase 1 trial testing β-globin restored autologous hematopoietic stem cells in Β-thalassemia in 8 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Shenzhen Hemogen |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 12 June 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 3 locations across China |
Drugs / interventions tested
- β-globin restored autologous hematopoietic stem cells
Conditions studied
- Β-thalassemia — all drugs for Β-thalassemia →
Sponsor
Shenzhen Hemogen — full company profile →
Who can join
Adults 6 to 35, any sex, with Β-thalassemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-arm, open label, multi-center, single-dose Phase 1 clinical trial in subjects with transfusion dependent β-thalassaemia. The study aims to evaluate the safety and efficacy of autologous lentiviral-transduced CD34+ human hematopoietic stem cells (hHSCs) using the gene therapy product HGI-001.
Publications & conference data
3 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 -
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 -
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:
- PubMed search for NCT06655662
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of β-globin restored autologous hematopoietic stem cells
Trials testing the same drug.
- NCT05864170 — the Safety and Efficacy Evaluation of HGI-001 Injection in Patients With Transfusion-Dependent β-Thalassemia · EARLY_PHASE1 · recruiting
- NCT05745532 — Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients · EARLY_PHASE1 · recruiting
Other Shenzhen Hemogen trials
Trials by the same sponsor.
- NCT05851105 — the Safety and Efficacy Evaluation of HGI-002 Injection in Patients With Transfusion-Dependent α-Thalassemia · EARLY_PHASE1 · recruiting
- NCT05864170 — the Safety and Efficacy Evaluation of HGI-001 Injection in Patients With Transfusion-Dependent β-Thalassemia · EARLY_PHASE1 · recruiting
- NCT05745532 — Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients · 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)
- Trial protocol + status: ClinicalTrials.gov NCT06655662 (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 Shenzhen Hemogen
- Last refreshed: 23 October 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/NCT06655662.
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