Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

  • STATUS
    Recruiting
  • End date
    Sep 10, 2025
  • participants needed
    48
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 7 October 2022
remission
ejection fraction
monoclonal antibodies
measurable disease
cell transplantation
cell therapy
anthracyclines
cancer chemotherapy
diffuse large b-cell lymphoma
mantle cell lymphoma
large b-cell lymphoma

Summary

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

Description

This is an open, single-arm, single-dose, dose-escalation clinical trial designed to evaluate the safety and the preliminary efficacy of CB CAR-NK019 cells in vivo. 9-18 patients are planned to be enrolled in the dose-escalation trial (2.5×10^8 cells/kg, 5×10^8 cells/kg, 1×10^9 cells/kg) . The primary endpoints are DLT, MTD, and the second endpionts are the overall response rates (CR and PR), overall survival, and progression-free survival. Based on the results in the dose-escalation trial, the recommended dose will be determined. Another 30 patients will be enrolled to estimate the safety and efficacy of CB CAR-NK019 under the best dose.

Details
Condition B-cell Non Hodgkin Lymphoma
Treatment anti-CD19 CAR-NK
Clinical Study IdentifierNCT05472558
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
-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

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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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