Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

November 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Occurrence of treatment related adverse events as assessed by CTCAE v4.0[ Time Frame: Day 3-Year 2 after injection ]

defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

Official Title ^ICMJE

An Observational Clinical Study on the Safety and Efficacy of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

Brief Summary

This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti CD22 CAR NK cells in patients with relapsed refractory B cell lymphoma

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Early Phase 1

Study Design ^ICMJE

Allocation:
Intervention Model: Sequential Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Biological: Anti-CD22 CAR NK Cells
Anti-CD22 CAR NK Cells injection

Study Arms

Experimental: Anti-CD22 CAR NK cells
Total dose of 50-600 thousand /kg Anti-CD22 CAR NK cells will be administered at day0

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 2021

Estimated Primary Completion Date

November 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry 2. Previously accepted ≥ first-line regimen chemotherapy 3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation 4. Over 18 years old and under 70 years old 5. The expected survival period is more than 3 months. 6. ECOG≤2 7. 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; 8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L; 9. 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. 10. Measurable target lesion Exclusion Criteria: 1. Patients with extramedullary relapse 2. Burkitt's lymphoma/leukemia 3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment; 4. Liver and kidney function: Total bilirubin > 2 × ULN (Gilbert Syndrome > 3 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN Serum creatinine clearance >60 mL/min 5. Serological examination: Absolute neutrophil count (ANC) <0.75×109/L Platelet count (PLT) <50×109/L 6. Active hepatitis B (HBV-DNA > 1000 copies / mL), hepatitis C, or uncontrolled infection 7. GVHD ≥ 2 or anti-GVHD treatment 8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before reinfusion, such as donor lymphocyte reinfusion; 9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks 10. Active CNS disease (tumor cells in CSF, but < 5 WBCs/mL can be included); 11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation 12. Creatinine > 1.5 times normal upper limit or ALT / AST > 3 times normal upper limit or bilirubin > 2 times normal upper limit 13. New York Heart Association (NYHA) graded above or above 14. Uncontrollable diabetes 15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining 16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Allife Medical Science and Technology Co., Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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