- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929107
Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma.
Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hui Liu, MD,PhD
- Phone Number: (+86)13819198629
Study Contact Backup
- Name: Juying Wei, MD
- Phone Number: (+86)13867476302
- Email: weijuy@hotmail.com
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- The First Affiliated Hospital of Zhejiang University
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Contact:
- Wenbin Qian, MD,PhD
- Phone Number: (+86)13605801032
- Email: qianwenb@aliyun.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete remission rate
Time Frame: at the time point 3 months after CAR-T cell transfusion
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complete remission rate after treated by CAR-T therapy
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at the time point 3 months after CAR-T cell transfusion
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adverse events
Time Frame: from the date of the start of treatment to 24 months after last patient's enrollment
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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
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from the date of the start of treatment to 24 months after last patient's enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free surviva
Time Frame: from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
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from date of inclusion to date of progression, relapse, or death from any cause
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from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
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overall survival
Time Frame: from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
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from the date of inclusion to date of death, irrespective of cause
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from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
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duration of the CAR-T cells in the patients
Time Frame: from the date of re-transfusison to 24 months after last patient's enrollment
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time from re-transfusion to date when the modified T cells become non-detectable.
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from the date of re-transfusison to 24 months after last patient's enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wenbin Qian, MD,PhD, Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lymphoma center Q003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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