CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

Study Overview
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Brief Summary
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Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Detailed Description
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CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Official Title
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Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma

Conditions
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B-Cell Lymphoma Stage I, Refractory, Relapsed

Intervention / Treatment
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* Biological: CD19/CD20 bispecific CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: expected lifetime>3 months CD19/CD20 positive relapsed/refractory B cell lymphoma KPS>70 at least one measurable lesion according to RECIST 1.1 enough function of hear, liver, kidney and bone marrow no history of severe allergies no other history of malignancy no other diseases that conflict with this regimen no serious mental illness patient or family member sign informed consent Exclusion Criteria: Pregnant or lactating women Severe infectious or viral disease Active B or C viral hepatitis Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks participated in other clinical studies in the last 3 months, or have been treated with other gene products Others not appropriate to participate in this study examined by the investigators

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>CAR-T cell group | Biological: CD19/CD20 bispecific CAR-T cells<br>* collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of study related adverse events | safety of CAR-T cells | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | proportion of patients with complete response and partial response | three months | 
| survival time of CAR-T cells in vivo | from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo | one year | 
| progression-free survival | the enrollment to the first time that disease progression is detected | one year |