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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-05-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

B019

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

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2026-01-31
Completion
2028-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927466 on ClinicalTrials.gov