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.

Phase 1

Recruiting

• Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: B019

• Registration Number: NCT06927466
• Lead Sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-19
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-01-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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

4. 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.

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.

5. 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B019	B019	-

Primary Outcome Measures

Name	Time	Method
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Approximately 2 years	Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Jiangxi Province pediatric hospital; 🇨🇳 Nanchang, China

Peking University People's Hospital; 🇨🇳 Beijing, 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