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

Not Applicable

• Conditions: Leukemia, B-Cell; Lymphoma, B-Cell; Minimal Disease, Residual
• Interventions: Biological: CD19-targeted CAR-T cells

• Registration Number: NCT03564977
• Lead Sponsor: Qingdao Central Hospital

Brief 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.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Last Update Submitted: 2018-06-28
• Last Update Posted: 2018-07-02
• Study Start: 2018-07-15
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19-targeted CAR-T cells	CD19-targeted CAR-T cells	-

Primary Outcome Measures

Name	Time	Method
Progress-free survival	2 years
Objective response rate	2 years
Disease control rate	2 years
Overall survival	2 years

Trial Locations

Locations (1)

Qingdao Central Hospital; 🇨🇳 Qingdao, Shandong, China