CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies

  • STATUS
    Recruiting
  • End date
    Nov 1, 2026
  • participants needed
    120
  • sponsor
    Zhejiang University
Updated on 26 January 2021

Summary

A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.

Description

This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.

Details
Condition Multiple Myeloma in Relapse, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphocytic Leukaemia Refractory, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory
Treatment CD19/BCMA Targeted CAR T-cells and dasatinib, CD19/BCMA Targeted CAR T-cells
Clinical Study IdentifierNCT04603872
SponsorZhejiang University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2)
Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions)
CR not achieved after standardized chemotherapy
CR achieved following the first induction, but CR duration is less than 12 months
Ineffectively after first or multiple remedial treatments
2 or more relapses
Relapse after hematopoietic stem cell transplantation
Extramedullary leisions which were ineffective to radiotherapy or chemotherapy
Total bilirubin 51 umol/L, ALT and AST 3 times of upper limit ofnormal, creatinine 176.8 umol/L
Echocardiogram shows left ventricular ejection fraction (LVEF) 50%
No active infection in the lungs, blood oxygen saturation in indoorair is 92%
Estimated survival time 12 weeks
ECOG performance status 0 to 2
Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion
Patients volunteer to participate in the study and sign the informed consent

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
Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids
Previously treated with any CAR-T cell product or other genetically-modified T cell therapies
Creatinine >2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin >2.0 mg/dl
Other uncontrolled diseases that were not suitable for this trial
Patients with HIV infection
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
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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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