Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    25
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 24 May 2021
remission
oxygen saturation
ejection fraction
monoclonal antibodies
measurable disease
cell transplantation
cell therapy
anthracyclines
follicular lymphoma
cancer chemotherapy
diffuse large b-cell lymphoma
mantle cell lymphoma
large b-cell lymphoma

Summary

To study the safety and effectiveness of HLA haploidentical CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma

Details
Condition B-Cell Lymphoma, Lymphoma, B-Cell
Treatment anti-CD19 CAR-NK
Clinical Study IdentifierNCT04887012
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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