Non Hodgkin Lymphoma
Conditions
Brief summary
To evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor T cell infusion in the treatment of relapsed or refractory CD19 positive non-Hodgkin's lymphoma.
Interventions
BIOLOGICALCD19 CAR-T cells infusion
Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment. CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10\^6/kg.
Sponsors
The First Affiliated Hospital of Zhengzhou University
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with CD19 positive, relapsed or refractory diffuse large B cell lymphoma and follicular lymphoma who have no effective treatment (such as autologous or allogeneic stem cell transplantation) and have a survival time of several months or less than 2 years must meet all of the following inclusion criteria, and those who do not meet any of the
Exclusion criteria
can be included: 1. Non Hodgkin's lymphoma was confirmed by histological examination, and one of the following conditions was met: 1. Relapsed and refractory CD19 positive diffuse large B-cell lymphoma: at least after the standard second-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission or disease progression after partial remission, or relapsed after complete remission; 2. Relapsed and refractory CD19 positive follicular lymphoma: at least after the standard three-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission and disease progress after partial remission, or relapsed after complete remission; 3. Relapsed refractory CD19 positive diffuse large B-cell lymphoma and follicular lymphoma: primary drug resistance; relapse within 1 year after autologous stem cell transplantation only, not affected by other treatment methods previously used; CD20 positive patients should receive corresponding targeted treatment; 2. Age: 18-65 years (including boundary value), gender unlimited; 3. The expected survival time was more than 3 months; 4. ECOG score 0-1 (dose increasing stage), ECoG score 0-2 (expanding group stage); 5. The functions of liver and kidney, heart and lung meet the following requirements: ① Creatinine ≤ 1.5 ULN ②ALT/AST ≤2.5 ULN； ③ Total bilirubin ≤ 1.5 × ULN; ④ Baseline oxygen saturation ≥ 92%; ⑤ No pericardial effusion was detected by echo; 6. According to Lugano's response standard, there should be at least one measurable tumor focus; 7. Be able to understand the test and have signed the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BORR | 6 months | Best objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AE | 2 years | Incidence of adverse reactions |
| Pharmacokinetic parameters | 90 Days | the area under the curve of 28 days AUC0-28d and 90 days AUC0-90d of targeting CD19 chimeric antigen receptor T cells in peripheral blood after administration |
| Overall survival time | through study completion, an average of 5 year | Overall survival time |
| Duration of remission after administration | through study completion, an average of 5 year | Duration of remission after administration |
| Disease progression free survival | through study completion, an average of 5 year | Disease progression free survival |
Countries
China
Contacts
Primary ContactMingzhi Zhang, Doctor
Outcome results
None listed