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CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation | Clinical Trials | Clareo Health

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

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

NCT03564977•Qingdao Central Hospital

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous 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 autologous count must \>= 0.2 x10\^9 / L;
•7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
•8. 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

•1. 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;
•2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
•3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
•4. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
•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 hormone therapy;
•8. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
•9. The Investigator believe the patients should not participate in this experiment.

Locations (1)

Qingdao Central Hospital

Qingdao, Shandong, China

Key Dates

Start Date

July 15, 2018

Primary Completion Date

June 15, 2020

Completion Date

June 15, 2020

Last Updated

July 2, 2018

Enrollment

ESTIMATED participants

Conditions

Lymphoma, B-CellLeukemia, B-CellMinimal Disease, Residual

Interventions

CD19-targeted CAR-T cells

BIOLOGICAL

Contacts

Peng Zhao, doctor

CONTACT

8653284961737 zp8102@126.com

Ketao Lana

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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