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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation

Conditions
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Lymphoma, B-Cell, Leukemia, B-Cell, Minimal Disease, Residual

Intervention / Treatment
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* Biological: CD19-targeted CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation. Age 18 to 75 years old, both male and female; Is expected to survive more than 3 months; Physical condition is good: ECOG score≤2; In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination. General requirements autologous as basic, normal blood T lymphocytes in autologous count must >= 0.2 x10^9 / L; No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body; Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form. Exclusion Criteria: Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more; Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution; Coagulation abnormalities and severe thrombosis; Pregnancy and lactation women; Any other chronic disease patients who have been treated with immune agents or hormone therapy; Patients who have participated in other clinical trials or other clinical trials in the past 30 days; The Investigator believe the patients should not participate in this experiment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD19-targeted CAR-T cells<br> | Biological: CD19-targeted CAR-T cells<br>* MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 2 years | 
| Disease control rate |  | 2 years | 
| Overall survival |  | 2 years | 
| Progress-free survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T, minimal residual disease, B cell maliganacy