Leukemia, B-Cell, Lymphoma, B-Cell, Minimal Disease, Residual
Conditions
Keywords
CAR-T, minimal residual disease, B cell maliganacy
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.
Interventions
BIOLOGICALCD19-targeted CAR-T cells
MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.
Sponsors
Yake Biotechnology Ltd.
Qingdao Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | 2 years |
| Disease control rate | 2 years |
| Overall survival | 2 years |
| Progress-free survival | 2 years |
Countries
China
Contacts
Primary ContactPeng Zhao, doctor
Backup ContactKetao Lana
Outcome results
None listed