About this trial
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma / leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma / leukemia.
Eligibility criteria
Qualifiers
Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
Age is 18-75 years old and gender is not limited;
Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;
Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;
Disqualifiers
Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;
Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;
Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;
Patients who have previously received any anti-CD19 / anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);
Trial design
Treatments tested in this trial
- JY231 Injection
Treatment groups
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
ChinaSponsors and collaborators
Shenzhen Genocury Biotech Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution