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.

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

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
• Intervention / Treatment: Biological: B019

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jing Chen; Phone Number: 0086-021-38626161; Email: chenjing@scmc.com.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Yifei Cheng
  • Nanchang, China
    • Recruiting
    • The First Affiliated Hospital of Nanchang University
    • Contact: Fei Li
  • Nanchang, China
    • Recruiting
    • Jiangxi Province pediatric hospital
    • Contact: Fei He
  • Shanghai, China
    • Recruiting
    • Shanghai Children's Medical Center
    • Contact: Jing Chen
  • Shanghai, China
    • Recruiting
    • Children's Hospital of Shanghai
    • Contact: Jingbo Shao
  • Suzhou, China
    • Recruiting
    • Children's Hospital of Soochow University
    • Contact: Shaoyan Hu
  • Wuhan, China
    • Recruiting
    • Tongji Hospital
    • Contact: Jia Kui
  • Xuzhou, China
    • Recruiting
    • The Affiliated Hospital of Xuzhou Medical University
    • Contact: zhenyu li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
2. Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
3. Documentation of CD19/CD22 tumor expression

3. 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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Exclusion Criteria:

1. Active CNS involvement by malignancy；
2. Isolated extramedullary leukemia recurrence；
3. Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
4. Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.

4. 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.

7. Other situations deemed inappropriate for participation in this study by the investigator.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B019	Biological: B019; B019： Intravenous infusion, 1.0×10^6 CAR T cell/kg-10.0×10^6 CAR T cell/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK(Pharmacokinetics):Tmax	Time to peak plasma concentration (Tmax)	Approximately 2 years
PK(Pharmacokinetics):Cmax	Maximum serum concentration(Cmax)	Approximately 2 years
The overall response rate (ORR)	Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.	3 months
Overall Survival (OS)	Determination of the overall survival times of all patients.	Approximately 2 years

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: B019-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No