- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932955
Recruitment Status Recruiting
First Posted May 1, 2019
Last update posted May 1, 2019
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma
|Experimental: MC-19PD1 CAR-T Cells
Biological: MC-19PD1 CAR-T cells
T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
（1）CD19 positive B-cell lymphoma; （2）Relapsed and refractory B-cell lymphoma: patients
previously received at least first-line and second- line treatment and fail to achieve CR;
（3）At least 1 measurable tumor foci according to the 2014 Lugano treatment response
criteria; （4）18 to 70 Years Old, Male and female; （5）Expected to survive for more than 3
months; （6）Clinical performance status of ECOG score 0-1; （7）Important organ function is
satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25
times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min;
ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥
80 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L.
（9）INR≤ 1.5times normal range; APTT≤ 1.5times normal range; （10）Women in childbearing age
must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion;
（11）Informed consent is signed by a subject or his lineal relation.
1. Recent or current use of glucocorticoid or other immunosuppressor or Drug that
stimulates bone marrow hematopoiesis;
2. Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections;
3. Active infection with HBV, HCV or HIV;
4. Patients with symptoms and disease history of central nervous system;
5. Pregnant or lactating female；The patient did not agree to use effective contraception
during the treatment period and for the following 1 year；
6. Patients receiving allogeneic hematopoietic stem cell transplantation, or organ
7. A history of other malignant tumors;
8. Primary immunodeficiency disease, or autoimmune disease;
9. Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment;
10. Patients who participated in other clinical trials within 4 weeks before blood
11. Patients who had used CD19 targeted therapy before enrollment;
12. The investigator believes that there are other factors that are not suitable for
inclusion or influence the subject's participation or completion of the study.
Contact: Chaoting Zhang, PhD 86-010-88196768 email@example.com
Peking University Cancer Hospital