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

Qingdao Central Hospital

Status: Unknown

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

Treatments: Biological: CD19-targeted CAR-T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03564977

QingdaoCH201805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CD19-targeted CAR-T cells

Experimental group

Treatment:

Biological: CD19-targeted CAR-T cells