B Cell Lymphoma
Conditions
Keywords
interleukin 7, Chemokine (C-C Motif) Ligand 19, CAR-T
Brief summary
It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma patients.
Interventions
BIOLOGICALInterleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells
patient's T cells were seperated and engineered into Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells, and retransfused into the patient for treatment of their B cell lymphoma.
Sponsors
Zhejiang Provincial Tongde Hospital
Wenbin Qian
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Age 18-75 years old, male or female; * 2\. ECOG 0-3, for patients with ECOG=4, if ECOG reach 0-3 after bridging treatment with ibrutinib, they are also considered to fit this criteria; * 3\. Histologically diagnosed as B cell non-Hodgkin's lymphoma (NHL)(according to WHO 2008 criteria), including DLBCL-NOS, primary mediastinal B cell lymphoma (PMBCL) mantel cell lymphoma (MCL), transformed follicular lymphoma (TFL) and other transformed B cell NHL; * 4\. CD19 positive (by immuno-histology or flowcytometry) \[for DLBCL/PMBCL/TFL patients, negative CD19 immuno-histology results also acceptable\]; * 5\. Definition of relapsed and refractory disease: 1) refractory DLBCL should fit one of the following: ①complete remission NOT achieved after 2nd line treatment; ②progression of disease during treatment; ③duration of stable disease \<6 months; ④ disease progress or relapse within 12 months of autologous stem cell transplantation. 2\) definition of refractory/relapsed disease for CLL and other indolent B cell NHL, should fit one of the following: ① failed or relapsed after 2nd therapy (Rituximab must be included) and being unable to accept ibrutinib treatment due to various reasons; ② non-responsive or intolerable to ibrutinib as 2nd line treatment; 3) refractory or relapsed MCL should fit one of the following: ① complete remission not achieved after 2nd line treatment; ② disease progression during treatment; ③duration of stable disease ≤6 months; ④disease progress or relapse within 12 months of autologous stem cell transplantation. * 6\. Previous treatment of aggressive B lymphomas must include Rituximab and anthracyclines; * 7\. Patients should have at least one measurable disease focus, with the longitudinal diameter ≥1.5cm, or any extra-nodal focus with the longitudinal diameter ≥1.0cm, with PET/CT positive results; * 8\. Blood routine test, absolute neutrophil count≥1000/ul、platelet count≥45000/ul； * 9\. Cardiac, hepatic and renal function: Creatinin \<1.5 times of normal maximum；ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of ULN；cardiac ejection fraction≥ 50%; * 10\. Patients should have the ability to fully understand contents of the written consent and be willing to sign the written consent; * 11\. Fertile patients should agree to take contraceptive measures during the process of this trial.
Exclusion criteria
* 1\. History of other malignant tumor; * 2\. History of autologous stem cell transplantation within 6 weeks prior to enrollment; * 3\. Received CAR-T therapy within 3 months prior to enrollment; * 4\. Received cytotoxic medicine or glucocorticoids or other targeted-therapy medicine (except for ibrutinib) within 2 weeks prior to T cell collection; * 5\. With active autoimmune disease; * 6\. With active infection; * 7\. With HIV infection, or uncontrolled HBV/HCV/syphilis infection; * 8\. With known central nervous system lymphoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | at the time point 3 months after CAR-T cell transfusion | complete remission rate after treated by CAR-T therapy |
| adverse events | from the date of the start of treatment to 24 months after last patient's enrollment | any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free surviva | from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment | from date of inclusion to date of progression, relapse, or death from any cause |
| overall survival | from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment | from the date of inclusion to date of death, irrespective of cause |
| duration of the CAR-T cells in the patients | from the date of re-transfusison to 24 months after last patient's enrollment | time from re-transfusion to date when the modified T cells become non-detectable. |
Countries
China
Contacts
Primary ContactJuying Wei, MD
Backup ContactHui Liu, MD,PhD
Outcome results
None listed