Lymphoma
Conditions
Brief summary
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.
Detailed description
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
Interventions
BIOLOGICALMC-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.
Sponsors
Peking University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
（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.
Exclusion criteria
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 transplantation 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 collection; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of adverse events | 2 years | Percentage of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective remission rate | 3 months | The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR) |
Countries
China
Contacts
Primary ContactChaoting Zhang, PhD
Outcome results
None listed