CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation

Last updated: June 28, 2018
Sponsor: Qingdao Central Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT03564977
QingdaoCH201805
  • Ages 18-75
  • All Genders

Study Summary

The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed by pathological biopsy in patients with B-cell malignancies and treated byautologous stem cell transplantation.

  2. Age 18 to 75 years old, both male and female;

  3. Is expected to survive more than 3 months;

  4. Physical condition is good: ECOG score≤2;

  5. In group of four weeks before Canon imaging examination evaluation body tumor load,recommend line PET - CT examination.

  6. General requirements autologous as basic, normal blood T lymphocytes in autologouscount must >= 0.2 x10^9 / L;

  7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on thebody;

  8. Into groups to participate in voluntarily, good adherence, can cooperate testobservation, childbearing age women must be 7 days before starting treatment expertpregnancy test and the results were negative, and signed a written informed consentform.

Exclusion

Exclusion Criteria:

  1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liverfunction grade C; kidney: kidney failure and uremia stage; lung: symptoms of severerespiratory failure; brain: disorder of consciousness;

  2. Existing serious acute infection, uncontrollable, or have fester sex and chronicinfection, wound in delay no more;

  3. Patients with significant graft versus host disease (GVHD) after organ transplanthistory or allogeneic hematopoietic stem cell transplantation;

  4. Systemic autoimmune diseases or immunodeficiency disease, patients with allergicconstitution;

  5. Coagulation abnormalities and severe thrombosis;

  6. Pregnancy and lactation women;

  7. Any other chronic disease patients who have been treated with immune agents or hormonetherapy;

  8. Patients who have participated in other clinical trials or other clinical trials inthe past 30 days;

  9. The Investigator believe the patients should not participate in this experiment.

Study Design

Total Participants: 20
Study Start date:
July 15, 2018
Estimated Completion Date:
June 15, 2020

Study Description

Relapse is a common cause of failure in patients with B-cell malignancies after autologous stem cell transplantation. CD19-targeted CAR-T cells showed excellent therapeutic efficiency in B-cell malignancies. Investigators attempt to treat minimal residual disease (MRD)-positive B-cell Malignancies after autologous stem cell transplantation by CD19-targeted CAR-T cells and hope to explore the therapeutic effects of CD19-targeted CAR-T cell therapy.

Connect with a study center

  • Qingdao Central Hospital

    Qingdao, Shandong 266042
    China

    Active - Recruiting

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