- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012879
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
July 7, 2019 updated by: Li Yu, Chinese PLA General Hospital
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Shenzhen, China, 518000
- Recruiting
- Shenzhen University General Hospital
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Principal Investigator:
- Lixing Wang, M.D.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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CD19 CART
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recovery rate of patients being treated with CD19CAR-T
Time Frame: 6 months
|
the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Anticipated)
April 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
June 28, 2019
First Submitted That Met QC Criteria
July 7, 2019
First Posted (Actual)
July 9, 2019
Study Record Updates
Last Update Posted (Actual)
July 9, 2019
Last Update Submitted That Met QC Criteria
July 7, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEM-ALL001-CART
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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