RecruitingPhase 1NCT06927466

A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.


Sponsor

Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

Enrollment

33 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.


Eligibility

Min Age: 3 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing B019 — a bispecific CAR T-cell therapy that simultaneously targets two proteins (CD19 and CD22) found on B-cell leukaemia cells — in patients with B-cell acute lymphoblastic leukaemia (B-ALL) that has relapsed or stopped responding to treatment. **You may be eligible if...** - You (or your guardian) are willing to participate and consent - You have been confirmed to have relapsed or refractory B-cell acute lymphoblastic leukaemia - Your leukaemia cells express CD19 and/or CD22 markers - Your liver, kidney, lung, and heart function meet acceptable levels - Your expected survival is more than 3 months - You are willing to use effective contraception for 1 year after the infusion **You may NOT be eligible if...** - Your leukaemia has spread into the brain or spinal fluid (active CNS involvement) - You have active severe infections - Your organ function is too impaired for the treatment 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALB019

B019: Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg


Locations(8)

Peking University People's Hospital

Beijing, China

Jiangxi Province pediatric hospital

Nanchang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Children's Hospital of Shanghai

Shanghai, China

Shanghai Children's Medical Center

Shanghai, China

Children's Hospital of Soochow University

Suzhou, China

Tongji Hospital

Wuhan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06927466


Related Trials