About this trial
To study the safety and effectiveness of cord blood-derived IL-10/IL-15 CD19-CAR NK in patients with B-cell non-Hodgkin's lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Volunteer to participate in this study and sign an informed consent form;
Age 18-75 years old, no gender limit;
Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:(1) Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ; (2) Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; (3) Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; (4) Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;
At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
Disqualifiers
Those who have a history of allergies to any of the ingredients in cell products;
History of other tumors;
Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;
Have received gene therapy in the past 3 months;
Trial design
Single group
Treatments tested in this trial
anti-CD19 IL10/IL15 CAR-NK
Biological/VaccineLentiviral vector-transducted cord blood-derived NK cells to express anti-CD19-IL10/IL-15 CAR
Treatment groups
Trial outcomes
Primary outcomes
Incidence of dose limiting toxicity (DLTs)
To evaluate the safety, and tolerability, and determine the recommended dosage of cord blood-derived Anti-CD19 IL10/IL15-CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma
Secondary outcomes
Complete response rate (CR)
To determine the anti-tumor effectivity of CB IL-10-CD19-CAR NK
Progression free survival (PFS)
Duration of response (DOR)
Overall survival (OS)
Sponsors and contacts
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