CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma

Study Overview
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Brief Summary
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The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.

Detailed Description
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The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy.

Official Title
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CAR-T Cell Therapy for Relapsed / Refractory CD19 Positive Clinical Study on the Safety and Effectiveness of Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: CD19-targeted CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is 16 years old, less than 70 years old, sex is not limited, race is not limited; The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation; The patient needs to have a lesion that can be used to detect or evaluate the disease. 0 1 score of physical status score of the eastern cancer cooperation group (ECOG). At the time of collection of peripheral white blood cell counts over 1 * 10^9/L; Expected survival time > 90 days; Patients have the ability to know and sign informed consent. Exclusion Criteria: Pregnant or lactating women; Uncontrolled infection; HIV infected people, hepatitis B or HCV active stage; Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.). Combined with active central nervous system malignant tumor invading; Has abnormal coagulation function, and there are patients with serious thrombus. Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system. Patients who participated in other clinical trials in the past 30 days or in other clinical trials; Researchers believe that patients are not suitable for the study.

Ages Eligible for Study
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Minimum Age: 16 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:the first day,the second day Duration:total two times | Biological: CD19-targeted CAR-T cells<br>* This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure: The overall efficiency | Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated | [Time Frame: 3 years] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma CAR-T