RecruitingEarly Phase 1NCT06045091

To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL

A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia


Sponsor

Hrain Biotechnology Co., Ltd.

Enrollment

18 participants

Start Date

Jul 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy that targets a protein called BCMA, which is found on the surface of myeloma cells. It is designed for patients with multiple myeloma (a blood cancer) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 or older - You have multiple myeloma confirmed by lab testing - Your BCMA protein levels meet the required threshold - You have received prior standard treatments that are no longer working - Your organ function (kidney, liver, heart) is within acceptable limits **You may NOT be eligible if...** - You have active serious infections - You have had prior BCMA-targeted CAR-T cell therapy - You are pregnant or breastfeeding - You have uncontrolled heart disease or serious organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuman BCMA targeted CAR-NK cells injection

Allogenic genetically modified anti-BCMA CAR transduced NK cells


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT06045091


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