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Autologous CD19-CD20-NKG2D-nsBicephali CAR-T for Relapsed/Refractory Central Nervous System Lymphoma
Sponsor: Beijing Boren Hospital
Summary
Central nervous system lymphoma (CNSL) includes primary CNS lymphoma (PCNSL) and secondary CNS lymphoma (SCNSL), with diffuse large B-cell lymphoma as the predominant pathological type. Disease progression is often rapid and the relapse rate is high. Current standard treatment is centered on CNS-directed regimens based on high-dose methotrexate (HD-MTX), but salvage options for relapsed or refractory disease remain limited. In addition, the blood-brain barrier restricts effective exposure of many drugs within the central nervous system, making deep remission and durable disease control difficult to achieve. This study evaluates autologous CD19-CD20-NKG2D-nsBicephali CAR-T in patients with relapsed or refractory PCNSL or SCNSL. By engineering the patient's T cells into effector cells capable of recognizing both CD19 and CD20, this approach is intended to address tumor antigen heterogeneity and reduce immune escape associated with downregulation or loss of a single target. CAR-T cells may also migrate into cerebrospinal fluid and brain parenchyma, expand within the CNS compartment, and directly eliminate CD19/CD20-positive lymphoma cells. The study is designed to systematically evaluate the safety and preliminary efficacy of this investigational CAR-T therapy in relapsed or refractory CNSL.
Official title: An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19-CD20-NKG2D-nsBicephali CAR-T for Relapsed/Refractory Central Nervous System Lymphoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-04
Completion Date
2029-12
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection
Autologous CD19-CD20-NKG2D-nsBicephali CAR-T is an autologous cell product derived from the participant's own cells. Peripheral blood mononuclear cells are collected by leukapheresis, T cells are isolated, and viral transduction is used ex vivo to generate autologous CAR-T cells for reinfusion. The product name stated in the protocol is Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection. Package specification is approximately 10-40 mL per dose. Transport condition is 2-8°C. Storage condition is sealed, protected from light, and maintained in liquid nitrogen conditions.
Locations (1)
Beijing GoBroad Boren Hospital
Beijing, Fengtai District, China