Sequential Low-dose Decitabine With PD-1/CD28 CD19 CAR-T in Relapsed or Refractory B-cell Lymphoma

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    30
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 20 June 2021

Summary

To evaluate the efficacy and safety of CD19 PD-1/CD28-CAR-T sequential low-dose decitabine in the treatment of relapse or refractory B cell lymphoma.

Details
Condition Objective Response Rate
Treatment CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine
Clinical Study IdentifierNCT04850560
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

(1) Age 18, upper limit 75, unlimited for men and women
(2) ECOG score 0-3
(3) Histologically confirmed diffuse large B-cell lymphoma (DLBCL) [according
to who 2008]
(4) CD19 was positive (immunohistochemistry or flow cytometry)
(5) The definition of refractory or relapse of DLBCL is: no complete remission
after 2-line treatment; disease progression in any treatment process, or
disease stabilization time equal to or less than 6 months; or disease
progression or relapse within 12 months after hematopoietic stem cell
transplantation
(6) The previous treatment of diffuse large B cell lymphoma must include
rituximab (CD20 mAb) and anthracycline
(7) There should be at least one measurable focus. It is required that any
length of lymph node focus should be greater than 1.5cm or any length of
extranodal focus should be greater than 1.0cm. PET-CT scan focuses should have
uptake (SUV is greater than liver blood pool)
(8) The absolute value of neutrophils in peripheral blood 1000 / L, platelet
L
(9) Heart, liver and kidney function: creatinine < 1.5mg/dl; ALT (alanine
aminotransferase) / AST (aspartate aminotransferase) 2.5 times lower than the
normal upper limit; total bilirubin < 1.5mg/dl; heart ejection fraction (EF)
%
(10) Sufficient understanding ability and voluntary signing of informed
consent
(11) Those with fertility must be willing to use contraceptive methods
(12) According to the judgment of the researchers, the expected survival time
is more than 4 months
(13) Willing to follow visit schedule, administration plan, laboratory
inspection and other test steps

Exclusion Criteria

(1) History of other tumors
(2) Hematopoietic stem cell transplantation was performed within 6 weeks
(3) Any target car-t treatment was performed within 3 months before the car-t
treatment
(4) Previous use of any commercially available PD-1 mAb
(5) Cytotoxic drugs, glucocorticoids and other targeted drugs were received
within 2 weeks before cell collection
(6) Active autoimmune diseases
(7) Uncontrollable infection of active bacteria and fungi
(8) HIV infection, syphilis infection; active hepatitis B or C: hepatitis B
HBV-DNA 1000IU / ml; hepatitis C: HCV RNA positive and liver function
abnormal
(9) Known central nervous system lymphoma
Clear my responses

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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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