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

Allife Medical Science and Technology Co., Ltd.0 sites9 target enrollmentMarch 2019

ConditionsRefractory B-Cell Lymphoma

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Refractory B-Cell Lymphoma
Sponsor: Allife Medical Science and Technology Co., Ltd.
Enrollment: 9
Primary Endpoint: Occurrence of treatment related adverse events as assessed by CTCAE v4.0
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2019

End Date

November 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Allife Medical Science and Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.
•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

Outcomes

Primary Outcomes

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.