Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK...

About this study

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

Condition: B-cell Non Hodgkin Lymphoma
Tested: anti-CD19 IL10/IL15 CAR-NK
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

Who can join

Age: 18 to 75 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 20

Minimum age: 18 years
Maximum age: 75 years
Study condition: B-cell Non Hodgkin Lymphoma
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;
The expected survival period is ≥12 weeks;
The puncture section of the tumor tissue was positive for CD19 expression; 7, ECOG score 0-2 points;
Sufficient organ function reserve: (1) Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
(2) Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
(3) Serum total bilirubin and alkaline phosphatase ≤1.5× UNL; （4）Glomerular filtration rate\>50Ml/min Cardiac ejection fraction (EF) ≥50%;
(5) Under natural indoor air environment, basic oxygen saturation\>92% .
Allow a previous stem cell transplantation.
The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;
Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;
Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial.
Two tests for the new coronavirus were negative.

Exclusion 10

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;
Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;
Hepatitis B (HBsAg positive, but HBV-DNA \<103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including but not limited to people living with HIV;
According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV impaired subjects;
Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);
Subjects with a history of epilepsy or other central nervous system diseases; 10. Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;
\. Have any other drugs that target CD19; 12. Women who are breastfeeding and unwilling to stop breastfeeding; 13. Any other situation that the investigator believes may increase the subject's risk or interfere with the test results.

Where

1 site, 1 recruiting

the Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Recruiting

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