Health Trials

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.

ConditionRelapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-25
SponsorShanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • B019

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov