CD19-targeted CAR-T cell Therapy for MRD of B-cell Lymphoma

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-ONC-16008911
• Date of registration: 2016-07-26
• Prospective Registration: Yes
• Primary sponsor: Tianjin First Central Hospital
• Public title: CD19-targeted CAR-T cell Therapy for MRD of B-cell Lymphoma
• Scientific title: CD19-targeted CAR-T cell Therapy for MRD of B-cell Lymphoma
• Date of first enrolment: 2016-10-01
• Target sample size: 1:20;2:20;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=15018
• Study type: Observational study
• Study design: Case series
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Deng Qi
• Affiliation: Tianjin First Central Hospital

• Name: Zhao Mingfeng
• Affiliation: Tianjin First Central Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. the patient or his/her legal guardians must sign a consent form;
2. the patient ages 6 years to 60 years, a male or female;
3. the patient was diagnosed with B-cell lymphoma by pathology, histology and flow cytometry;
4. the patient has lesions which can be measured or evaluated;
5. main organs seem to be functioning well:
Liver function: bilirubin=34.2umol/L;
Renal function: Serum creatinine<220umol/L;
Lung function: arterial oxygen saturation=95%;
Heart function: LVEF=40%;
6. peripheral venous blood in patients flow smoothly;
7. Karnofsky score=60.
Exclusion criteria: 1. pregnant or lactating women;
2. patients who want to be pregnant in 1 year;
3. patients who can not use contraception in 1 year;
4. uncontrolled active infection with in 4 weeks;
5. active hepatitis B or hepatitis C virus infection;
6. HIV infected patients;
7. patients with other cancers diagnosised by pathology;
8. patients with serious autoimmune diseases or immunodeficiency;
9. patients who suffer from allergies;
10. patients who have taken part in other clinical tests within 6 weeks;
11. patients who use systemic steroids before treatment within 4 weeks;
12. patients who have a history of central nervous system disease;
13. patients who are addicted to some drugs;
14. patients who are not allowed to take part in the test(judged by the researchers).

Age minimum: 6
Age maximum: 60
Gender: Both

Health Condition(s) or Problem(s) studied

B-cell Lymphoma

Intervention(s)

1:CAR-T cells with normol expression of PD-1;2:CAR-T cells with low expression of PD-1;

Primary Outcome(s)

minimal residual disease;amplification and duration of CART;remission rate;

Source(s) of Monetary Support

Tianjin Health Bureau/Tianjin First Central Hospital