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.
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Interventions
BIOLOGICALB019
B019: Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06927466