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

June 28, 2018 updated by: Qingdao Central Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peng Zhao, doctor
  • Phone Number: 8653284961737
  • Email: zp8102@126.com

Study Contact Backup

  • Name: Ketao Lana

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Qingdao Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ketao Lan, M.D
        • Sub-Investigator:
          • Xuezhen Ma, M.D
        • Sub-Investigator:
          • Ling Wang, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Collaborators

Yake Biotechnology Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2018

Primary Completion (Anticipated)

June 15, 2020

Study Completion (Anticipated)

June 15, 2020

Study Registration Dates

First Submitted

June 11, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QingdaoCH201805

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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