interleukin-7 and chemokine (c-c motif) ligand 19-expressing cd19-car-t for refractory/relapsed b cell lymphoma.

Conditions: B Cell Lymphoma

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.


Eligibility criteria:
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.

Keywords: interleukin 7, chemokine (c-c motif) ligand 19, car-t