CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation

Lymphoma, B-Cell Clinical Trial

Official title:

CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03564977
• Other study ID #: QingdaoCH201805
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: June 15, 2020

Study information

• Verified date: June 2018
• Source: Qingdao Central Hospital
• Contact: Peng Zhao, doctor
• Phone: 8653284961737
• Email: zp8102[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.

Description:

Relapse is a common cause of failure in patients with B-cell malignancies after autologous stem cell transplantation. CD19-targeted CAR-T cells showed excellent therapeutic efficiency in B-cell malignancies. Investigators attempt to treat minimal residual disease (MRD)-positive B-cell Malignancies after autologous stem cell transplantation by CD19-targeted CAR-T cells and hope to explore the therapeutic effects of CD19-targeted CAR-T cell therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.

2. Age 18 to 75 years old, both male and female;

3. Is expected to survive more than 3 months;

4. Physical condition is good: ECOG score=2;

5. In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.

6. General requirements autologous as basic, normal blood T lymphocytes in autologous count must >= 0.2 x10^9 / L;

7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;

8. 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. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;

4. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;

5. Coagulation abnormalities and severe thrombosis;

6. Pregnancy and lactation women;

7. Any other chronic disease patients who have been treated with immune agents or hormone therapy;

8. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;

9. The Investigator believe the patients should not participate in this experiment.

Related Conditions & MeSH terms

• Leukemia, B-Cell
• Lymphoma, B-Cell
• Minimal Disease, Residual
• Neoplasm, Residual

Intervention

Biological:
• CD19-targeted CAR-T cells
MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.

Locations

Country	Name	City	State
China	Qingdao Central Hospital	Qingdao	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qingdao Central Hospital	Yake Biotechnology Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		2 years
Primary	Disease control rate		2 years
Primary	Overall survival		2 years
Primary	Progress-free survival		2 years