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

NCT03929107 | Unknown Phase 2

• 1 other identifier: lymphoma center Q003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

interleukin 7, Chemokine (C-C Motif) Ligand 19, CAR-T

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

• overall survival

  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

  from the date of re-transfusison to 24 months after last patient's enrollment

Study Arms (1)

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.

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

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-75 years old, male or female;
• \. 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;
• \. 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;
• \. CD19 positive (by immuno-histology or flowcytometry) \[for DLBCL/PMBCL/TFL patients, negative CD19 immuno-histology results also acceptable\];
• \. 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.
• \) 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.
• \. Previous treatment of aggressive B lymphomas must include Rituximab and anthracyclines;
• \. 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;
• \. Blood routine test, absolute neutrophil count≥1000/ul、platelet count≥45000/ul；
• \. 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%;
• \. Patients should have the ability to fully understand contents of the written consent and be willing to sign the written consent;
• \. Fertile patients should agree to take contraceptive measures during the process of this trial.

You may not qualify if:

• \. History of other malignant tumor;
• \. History of autologous stem cell transplantation within 6 weeks prior to enrollment;
• \. Received CAR-T therapy within 3 months prior to enrollment;
• \. Received cytotoxic medicine or glucocorticoids or other targeted-therapy medicine (except for ibrutinib) within 2 weeks prior to T cell collection;
• \. With active autoimmune disease;
• \. With active infection;
• \. With HIV infection, or uncontrolled HBV/HCV/syphilis infection;
• \. With known central nervous system lymphoma.

Sponsors & Collaborators

• Wenbin Qian: lead
• Zhejiang Provincial Tongde Hospital: collaborator

Study Sites (1)

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Interleukin-7; Chemokines

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chemotactic Factors; Inflammation Mediators

Study Officials

• Wenbin Qian, MD，PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juying Wei, MD

CONTACT

(+86)13867476302; weijuy@hotmail.com

Hui Liu, MD,PhD

CONTACT

(+86)13819198629

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 26, 2019
• Study Start: March 28, 2019
• Primary Completion: January 31, 2022
• Study Completion: April 30, 2022
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

CN (1)