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

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

Min Age: 3 YearsMax Age: 25 Years

The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
Documentation of CD19/CD22 tumor expression
\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.
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Active CNS involvement by malignancy；
Isolated extramedullary leukemia recurrence；
Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.
\. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.
\. Other situations deemed inappropriate for participation in this study by the investigator.
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BIOLOGICALB019

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

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

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NCT06927466