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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
JY231 Injection
DrugThis study employs two pretreatment regimens: In the lymphodepletion regimen, upon enrollment, subjects undergo leukapheresis followed by 3-5 days of lymphodepleting therapy with fludarabine and cyclophosphamide, culminating in intravenous infusion of JY231 and autologous patient PBMCs via a double-lumen catheter; in the non-lymphodepletion regimen, subjects receive direct intravenous injection of the JY231 preparation immediately after enrollment.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Secondary outcomes
Objective Response Rate
Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR)
Sponsors and contacts
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