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Clinical Trial Summary

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.


Clinical Trial Description

Subjects with relapsed/refractory multiple myeloma or plasma cell leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography (CT)/Magnetic Resonance Imaging (MRI)/Positron Emission Tomography (PET), liver/renal function tests, complete blood count with differential and complete metabolic profile and etc. Subjects will receive preconditioning chemotherapy prior to the first infusion of human BCMA targeted CAR-NK Cells injection. After the infusion, subjects will be followed for adverse events, pharmacokinetic/pharmacodynamics characteristics, efficacy of human BCMA targeted CAR-NK cells. Study procedures may be performed while hospitalized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06045091
Study type Interventional
Source Hrain Biotechnology Co., Ltd.
Contact Xuedong Sun, Doctor
Phone +8615811287219
Email sunxuedong@dashengbio.com
Status Recruiting
Phase Early Phase 1
Start date July 4, 2023
Completion date September 30, 2027

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