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| Name | Class |
|---|---|
| Zhejiang Provincial Tongde Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | In this group, patients will be treated with Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T, and the safety and efficacy will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | complete remission rate after treated by CAR-T therapy | at the time point 3 months after CAR-T cell transfusion |
| adverse events | 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 | from the date of the start of treatment to 24 months after last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| progression free surviva | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment |
| overall survival |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juying Wei, MD | Contact | (+86)13867476302 | weijuy@hotmail.com | |
| Hui Liu, MD,PhD | Contact | (+86)13819198629 |
| Name | Affiliation | Role |
|---|---|---|
| Wenbin Qian, MD,PhD | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015851 | Interleukin-7 |
| D018925 | Chemokines |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
from the date of inclusion to date of death, irrespective of cause
| from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment |
| duration of the CAR-T cells in the patients | time from re-transfusion to date when the modified T cells become non-detectable. | from the date of re-transfusison to 24 months after last patient's enrollment |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002630 | Chemotactic Factors |
| D018836 | Inflammation Mediators |