CAR-T for R/R B-NHL

Study Overview
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Brief Summary
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This study is a single arm study to investigate the efficacy and safety of CAR-T targeted CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for at least 2 years.

Official Title
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Safety and Efficacy of Chimeric Antigen Receptor T Cell (CAR-T) Treating Relaspe/Refractory CD19/CD20/CD22/CD30 Postive Non-Hodgkin Lymphoma

Conditions
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Relapsed Non Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, CAR - T CD19/CD20/CD22/CD30

Intervention / Treatment
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* Biological: CAR-T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological detection confirmed CD19/CD20/CD22/CD30 postive non-Hodgkin lymphoma Recieved more than 2 lines of chemotherapy With contraindications of hematopoietic stem cell transplantation or relapse after hematopoietic stem cell transplantation Expected survival more than 3 months Karmofsky performance score ≤ 60, and ECOG ≥ 2. Enough organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92% CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion With measurable disease Written informed consent could be acquired Exclusion Criteria: Received immunol suppression treatment or steroids in recent 1 week before recruitment Uncontrolled infection HIV positive patients Active HBV or HCV infection Women in pregnancy and lactation Refuse to conception control during treatment and 1 year after CAR-T infusion Uncured malignancies other than non-Hodgkin lymphoma Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma Inheritated immune deficiancy Severe heart disease

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>the group of patients who received CAR-T treatment | Biological: CAR-T<br>* For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Rate of complete remission and patial remission | One months after CAR-T cells were infused | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse toxicity | Accordingto CTCAE 4.0 criteria | Day 0, day 4, week 1, week 3, week 4, month 2, month 24 after CAR-T cells were infused | 
| CAR-T cell survival | the survival of CAR-T cells detected in patients' peripheral blood | every week in first 4 weeks after CAR-T cells infusion, then every 3 months for 2 years, then every 6 months for next 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse/refractory non-Hodgkin lymphoma, CAR - T CD19/CD20/CD22/CD30