Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJuly 9, 2019
July 1, 2019
2 years
June 28, 2019
July 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
recovery rate of patients being treated with CD19CAR-T
the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
6 months
Study Arms (1)
study group
EXPERIMENTALAfter 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
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive
- Age 18 to 65 years old, both male and female;
- Is expected to survive more than 12 weeks;
- Physical condition is good: 0-1 score ECOG score;
- No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
- 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.
You may not qualify if:
- 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;
- Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
- Pregnancy and lactation women;
- Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
- The Investigator believe the patients should not participate in this experiment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Shenzhen University General Hospitalcollaborator
Study Sites (1)
Shenzhen University General Hospital
Shenzhen, 518000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 9, 2019
Study Start
May 1, 2019
Primary Completion
April 30, 2021
Study Completion
June 30, 2021
Last Updated
July 9, 2019
Record last verified: 2019-07