Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT ID: NCT04012879
Last Updated: 2019-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2019-05-01
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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study group
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10\^4 cells/kg in 36-96 hours
CD19 CART
CD19 CART
Interventions
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CD19 CART
CD19 CART
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Shenzhen University General Hospital
OTHER
Chinese PLA General Hospital
OTHER
Responsible Party
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Li Yu
Professor
Locations
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Shenzhen University General Hospital
Shenzhen, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HEM-ALL001-CART
Identifier Type: -
Identifier Source: org_study_id
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