Study of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

Study Overview
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Brief Summary
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This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 CAR NK cells in patients with relapsed refractory B cell lymphoma.

Official Title
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An Observational Clinical Study on the Safety and Efficacy of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

Conditions
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Refractory B-Cell Lymphoma

Intervention / Treatment
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* Biological: Anti-CD19 CAR NK Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry Previously accepted ≥ first-line regimen chemotherapy Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation Over 18 years old and under 70 years old The expected survival period is more than 3 months. ECOG≤2 Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL; Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L; The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year. Measurable target lesion Exclusion Criteria: Patients with extramedullary relapse Burkitt's lymphoma/leukemia Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment; Liver and kidney function: Total bilirubin > 2 x ULN (Gilbert Syndrome > 3 x ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN Serum creatinine clearance >60 mL/min Serological examination: Absolute neutrophil count (ANC) <0.75x109/L Platelet count (PLT) <50x109/L Active hepatitis B (HBV-DNA > 1000 copies / mL), hepatitis C, or uncontrolled infection GVHD ≥ 2 or anti-GVHD treatment IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion; Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks Active CNS disease (tumor cells in CSF, but < 5 WBCs/mL can be included); Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation Creatinine > 1.5 times normal upper limit or ALT / AST > 3 times normal upper limit or bilirubin > 2 times normal upper limit New York Heart Association (NYHA) graded above or above Uncontrollable diabetes Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining Any situation that the investigator believes may increase the risk of the subject or interfere with the test results

Ages Eligible for Study
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Minimum Age: 18 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: Anti-CD19 CAR NK Cells<br>Total dose of 50-600 thousand /kg Anti-CD19 CAR NK cells will be administered at day0 | Biological: Anti-CD19 CAR NK Cells<br>* Anti-CD19 CAR NK Cells injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment related adverse events as assessed by CTCAE v4.0 | Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment. | Day 3-Year 2 after injection |