Status:
UNKNOWN
Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
B-cell Non Hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
To study the safety and effectiveness of HLA haploidentical CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma
Eligibility Criteria
Inclusion
- 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:
- 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;
- 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;
- ECOG score 0-2 points;
- Sufficient organ function reserve:
- Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
- Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
- Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
- Glomerular filtration rate\>50Ml/min
- Cardiac ejection fraction (EF) ≥50%;
- 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
- 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;
- Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;
- Have received any other drugs that target CD19;
- Women who are breastfeeding and unwilling to stop breastfeeding;
- Any other situation that the investigator believes may increase the risk of the subject or interfere with the results of the test.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04887012
Start Date
May 1 2021
End Date
May 1 2024
Last Update
May 14 2021
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009