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

Chinese PLA General Hospital1 site in 1 country12 target enrollmentMay 1, 2019

ConditionsRelapsed Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed Acute Lymphoblastic Leukemia
Sponsor: Chinese PLA General Hospital
Enrollment: 12
Locations: 1
Primary Endpoint: recovery rate of patients being treated with CD19CAR-T
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2019

End Date

June 30, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Li Yu

Professor

Chinese PLA General Hospital

Eligibility Criteria

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.