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Recruiting NCT06940960

JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia

Trial Parameters

Condition B Acute Lymphoblastic Leukemia
Sponsor Affiliated Hospital of Guangdong Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 12 Years
Max Age 75 Years
Start Date 2025-05-30
Completion 2027-12
Interventions
JY231 Injection

Brief Summary

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

Inclusion Criteria: 1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements; 2. Age is 12-75 years old and gender is not limited; 3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis; 4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions: 1. 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 remis

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