Refractory Acute Lymphoblastic Leukemia, Relapsed Acute Lymphoblastic Leukemia
Conditions
Brief summary
This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory acute lymphoblasic leukemia.
Interventions
COMBINATION_PRODUCTCD19 CART
CD19 CART
Sponsors
Shenzhen University General Hospital
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive 2. Age 18 to 65 years old, both male and female; 3. Is expected to survive more than 12 weeks; 4. Physical condition is good: 0-1 score ECOG score; 5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body; 6. 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. Pregnancy and lactation women; 4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days; 5. The Investigator believe the patients should not participate in this experiment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recovery rate of patients being treated with CD19CAR-T | 6 months | the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T |
Countries
China
Contacts
Primary ContactLixing Wang, M.D.
Outcome results
None listed