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UNKNOWNPhase 1NCT04012879

Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia

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.

Lead sponsor: Chinese PLA General Hospital•1 locations•View source on ClinicalTrials.gov

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Contacts

Lixing Wang, M.D.

CONTACT

86-0755-21839178 wanglixin1991@sohu.com

Sponsors

Lead Sponsor

Chinese PLA General Hospital

Collaborators

Shenzhen University General Hospital

Age

18 - 65 years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 9, 2019Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE1

Enrollment12

Start dateMay 2019

Last updatedJul 9, 2019

Condition

Relapsed Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia

Locations shown

Shenzhen University General Hospital

Shenzhen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2019Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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