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Clinical Trials in China / NCT06308159
Active, not recruiting Phase 1/2

An Open-label Study of a Gene Therapy Product (Vebeglogene Autotemcel) in Transfusion Dependent Beta-Thalassemia

NCT06308159 · tracked via the Priya Life Science China tracker
Sponsor
Lantu Biopharma
Phase
Phase 1/2
Started
2024-05-11
Last updated
2026-06-15

Condition(s) studied

Beta-Thalassemia

Investigational drug(s) / intervention(s)

Vebeglogene autotemcel

Vebeglogene autotemcel: Autologous HSPCs transduced with self-inactivating lentiviral vector encoding functional HBB gene and resuspended in cryopreservative solution in the final immediate container for the intended medical use.

Study summary

This is an interventional study to evaluate the safety and efficacy of autologous Hematopoietic Stem and Progenitor Cells (HSPCs) transduced with lentiviral vector encoding functional hemoglobin subunit beta (HBB) gene in patients with transfusion-dependent beta-thalassemia.

Eligibility

Sex
ALL
Min age
Max age
35 Years
Healthy volunteers
No
Inclusion Criteria: * Patients or parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedules. * Diagnosis of beta-thalassemia and a history of RBCs transfusions. * Documented baseline, or pretransfusion, Hb≤7 g/dL. * Availability of an adequate and well-documented transfusion history. Exclusion Criteria: * Active bacterial, viral, fungal, or parasitic infection. * A white blood cell (WBC) counts\<3×10\^9/L, and/or platelet counts\<100×10\^9/L not related to hypersplenism. * Uncorrected bleeding disorder. * Presence of severe diseases that judged not compatible with the study procedures, such as severe hepatic disease, kidney disease, lung disease, and/or cardiovascular disease. * Uncontrolled seizure disorder. * Any evidence of severe iron overload that, in the investigator's opinion, warrants exclusion. * Prior autologous hematopoietic stem cell transplantation. * Prior receipt of gene therapy.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China Kunming Yunnan
Kunming Hope of Health Hospital Kunming Yunnan

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06308159 on ClinicalTrials.gov ↗ ← All trials in China