Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma.

NCT ID: NCT03929107

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2022-04-30

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.

Conditions

B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells

Intervention Type: 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.

Interventions

Interleukin-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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role: collaborator

Wenbin Qian

OTHER

Sponsor Role: lead

Responsible Party

Wenbin Qian

Doctor, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wenbin Qian, MD，PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Juying Wei, MD

Role: CONTACT

weijuy@hotmail.com

(+86)13867476302

Hui Liu, MD,PhD

Role: CONTACT

(+86)13819198629

Facility Contacts

Wenbin Qian, MD,PhD

Role: primary

qianwenb@aliyun.com

(+86)13605801032

Other Identifiers

lymphoma center Q003

Identifier Type: -

Identifier Source: org_study_id