Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    50
  • sponsor
    Zhejiang University
Updated on 24 March 2022
remission
chronic lymphocytic leukemia
lymphoma
filgrastim
granulocyte colony stimulating factor
cell transplantation
leukemia
chemotherapy regimen
follicular lymphoma
b-cell lymphoma

Summary

Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma

Description

Current studies have shown that under standard treatment, patients with large masses and high-grade DLBCL have a poor prognosis. Data from major centers around the world on CAR-T cell treatment of relapsed and refractory B-cell NHL show that CAR-T treatment of relapsed and refractory B-cell NHL has a low complete remission rate but a low recurrence rate after remission.Therefore, new treatment options are urgently needed to achieve long-term relief.

CD19 CAR-T therapy as a consolidation therapy after high-dose melphalan and autologous hematopoietic stem cell transplantation has been used in a refractory MM patient at the University of Pennsylvania, and good research progress has been made. Craig S et al. studied the safety and effectiveness of CD19 CAR-T cell therapy after high-dose chemotherapy and autologous stem cell transplantation HDT-ASCT. The object of the study was relapsed and refractory non-Hodgkin's lymphoma, with 2-year progression-free survival ( PFS) is 30%.

Therefore, autologous hematopoietic stem cell transplantation combined with CAR-T cell therapy is expected to improve the complete remission rate and long-term survival rate. In summary, the center intends to apply for a clinical trial of autologous hematopoietic stem cell transplantation combined with CAR-T cells for the treatment of refractory and relapsed non-Hodgkin's lymphoma.

Details
Condition Lymphoma
Treatment Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
Clinical Study IdentifierNCT05239676
SponsorZhejiang University
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmed include: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphoma Subject
R/R B-NHL (conform one of the following conditions)
The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy
Primary resistance
The subject relapsed after receiving autologous hematopoietic stem cell transplantation

Exclusion Criteria

Subjects with any of the following exclusion criteria were not eligible for this
trial
History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases
Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past
Pregnant (or lactating) women
Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis)
Active infection of hepatitis B virus or hepatitis C virus
Those who have used any gene therapy products before
The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal
Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl
Those who suffer from other uncontrolled diseases are not suitable to join the study
HIV infection
Any situation that the researchers believe may increase the risk of patients or interfere with the test results
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