Β-Thalassemia Treatment with KL003 Cell Injection

Recruiting Phase 1 Phase 2 Interventional Study
Transfusion-dependent Beta-Thalassemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 – 35
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
41 (estimated)
Sponsor
Kanglin Biotechnology (Hangzhou) Co., Ltd. · Industry
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About This Trial

This is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. The goal of this clinical trial is to evaluate the safety and efficacy of KL003 cell injection in subjects with β-thalassemia major.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male or female age between 3-35 years; * Diagnosis of transfusion-dependent β-thalassemia and a history of at least 100 mL/kg/year of pRBCs or ≥8 transfusions of pRBCs per year for the prior 2 years; * Karnofsky performance status ≥70 for participants≥16 years of age; Lansky p…
Contacts

jingfeng Yan

+86 18852138866

yanjingfeng@kanglinbio.com

CONTACT