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

Refractory Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012879
• Other study ID #: HEM-ALL001-CART
• Status: Recruiting
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2019
• Source: Chinese PLA General Hospital
• Contact: Lixing Wang, M.D.
• Phone: 86-0755-21839178
• Email: wanglixin1991[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Refractory Acute Lymphoblastic Leukemia
• Relapsed Acute Lymphoblastic Leukemia

Intervention

Combination Product:
• CD19 CART
CD19 CART

Locations

Country	Name	City	State
China	Shenzhen University General Hospital	Shenzhen

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Shenzhen University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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