JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Genocury Biotech Co., Ltd.
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
20 Participants
are divided into 1 treatment groupLocations
1The First Affiliated Hospital of Zhengzhou University ZhengzhouHenan, China
Sponsors and collaborators
Shenzhen Genocury Biotech Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov