About this trial
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years old, no gender limit;
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 ;
Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;
Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;
Disqualifiers
Allergic to any of the components of cell products;
History of other tumors;
Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;
Had received gene therapy within the past 3 months;
Trial design
Single group
Treatments tested in this trial
CD19-CAR-NK/T
Biological/VaccineCord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T
Treatment groups
Trial outcomes
Primary outcomes
Incidence of dose limiting toxicity (DLTs)
To evaluate the safety and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Secondary outcomes
Overall survival (OS)
To determine the OS of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Progression free survival (PFS)
To determine the anti-tumor efficacy of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Duration of response (DOR)
To determine the DOR of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Complete response rate (CR)
To determine the CR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma
Sponsors and contacts
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