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Β-Thalassemia Treatment with KL003 Cell Injection

NCT06280378 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-03-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

KL003 Cell Injection Drug Product

Administered by intravenous infusion after myeloablative conditioning with busulfan.

Sponsors & Collaborators

  • Kanglin Biotechnology (Hangzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Haoquan Wu, PhD · R&D Kanglin Biotech

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2025-10-31
Completion
2027-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280378 on ClinicalTrials.gov