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

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

Recruiting
18-70 years
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
  2. Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions):
    1. CR not achieved after standardized chemotherapy;
    2. CR achieved following the first induction, but CR duration is less than 12 months;
    3. Ineffectively after first or multiple remedial treatments;
    4. 2 or more relapses;
    5. Relapse after hematopoietic stem cell transplantation;
    6. Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;
  3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine

    ≤ 176.8 umol/L;

  4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  6. Estimated survival time ≥ 12 weeks;
  7. ECOG performance status 0 to 2;
  8. 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.
  9. 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:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
  7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  8. Creatinine >2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin >2.0 mg/dl;
  9. Other uncontrolled diseases that were not suitable for this trial;
  10. Patients with HIV infection;
  11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Study details
    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

NCT04603872

Zhejiang University

25 January 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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