Clinical trial NCT03564977: CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation
Official title: CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, B-Cell
Leukemia, B-Cell
Minimal Disease, Residual
Keywords: CAR-T
minimal residual disease
B cell maliganacy
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
Collaborators: name: Yake Biotechnology Ltd.
First posted: 2018-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: 2 years
measure: Disease control rate
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Progress-free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
Study officials:
References: