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.

NCT06927466 | Recruiting Phase 1

• 1 other identifier: B019-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• (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 Outcomes (4)

• The overall response rate (ORR)

  3 months

• Overall Survival (OS)

  Approximately 2 years

• PK(Pharmacokinetics):Tmax

  Approximately 2 years

• PK(Pharmacokinetics):Cmax

  Approximately 2 years

Study Arms (1)

B019

EXPERIMENTAL

Biological: B019

Interventions

B019 BIOLOGICAL

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

B019

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

Peking University People's Hospital

Beijing, China

RECRUITING

Jiangxi Province pediatric hospital

Nanchang, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Children's Hospital of Shanghai

Shanghai, China

RECRUITING

Shanghai Children's Medical Center

Shanghai, China

RECRUITING

Children's Hospital of Soochow University

Suzhou, China

RECRUITING

Tongji Hospital

Wuhan, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jing Chen

CONTACT

0086-021-38626161; chenjing@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: September 19, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-04

Locations

CN (8)