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

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

Sponsors

Lead Sponsor: Allife Medical Science and Technology Co., Ltd.

Collaborator: Beijing Cancer Hospital

Source Allife Medical Science and Technology Co., Ltd.
Brief Summary

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

Overall Status Unknown status
Start Date 2019-02-01
Completion Date 2021-01-01
Primary Completion Date 2020-01-01
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Occurrence of treatment related adverse events as assessed by CTCAE v4.0 1 year
Enrollment 10
Condition
Intervention

Intervention Type: Biological

Intervention Name: Anti-CD19 iCAR NK Cells

Description: Anti-CD19 iCAR NK Cells injection

Arm Group Label: Anti-CD19 iCAR NK Cells

Eligibility

Criteria:

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 x ULN (Gilbert Syndrome > 3 x ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN - Serum creatinine clearance >60 mL/min 5. Serological examination: - Absolute neutrophil count (ANC) <0.75x109/L - Platelet count (PLT) <50x109/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 infusion, such as donor lymphocyte infusion; 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2019-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Anti-CD19 iCAR NK Cells

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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