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Combination for treating high-risk acute myeloid leukemia

A technology for acute myeloid and leukemia, applied in the field of biomedicine, can solve problems such as high recurrence rate and affect curative effect, and achieve the effect of reducing recurrence and improving cure rate.

Inactive Publication Date: 2019-08-30
SHENZHEN HANK BIOLOG ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the high recurrence rate after stem cell transplantation is the main reason affecting its efficacy

Method used

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  • Combination for treating high-risk acute myeloid leukemia
  • Combination for treating high-risk acute myeloid leukemia
  • Combination for treating high-risk acute myeloid leukemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1 Preparation and infusion of donor-derived NK cells

[0019] About 50 ml of peripheral blood was collected from the donor on day 15 before stem cell transplantation.

[0020] HANK cells were cultured under GMP conditions using clinical grade reagents. Stimulate NK cell expansion and activation in PBMCs using the Human NK Cell In Vitro Culture Booster Kit according to the manufacturer's instructions. The purity of CD3-CD56+ cells was determined by flow cytometry BD ACCURI C6 (BD Pharmingen, USA) after staining with FITC-anti-human CD3 and PE-anti-human CD56. K562 target cells were labeled with CFSE, and the ratio of effector cells to target cells was 20:1; after 4 hours of reaction, the cytotoxic activity of donor-derived NK cells was measured by flow cytometry.

[0021] Donor-derived NK cells were infused 6 hours prior to transplantation of donor stem cells. Its purity is 88.5% ( figure 1 ), the killing rate of NK cells to K562 target cells was 90.5% ( fi...

Embodiment 2

[0023] Example 2 Stem Cell Transplantation and GVHD Prevention

[0024] Patients received a FBCA conditioning regimen consisting of intravenous fludarabine (25 mg / m 2 / day), intravenous injection of busulfan (3.2mg / kg / day) from the -8th day to the -5th day, intravenous injection of CTX (60mg / kg / day) from the -6th day to the -2nd day, and the - Intravenous injection of ATG (2.5mg / kg / day) on days 5 to -1. On day -4 and day 0, the donors were subcutaneously injected with G-CSF twice, with a total dose of 10 μg / kg. On day 0, G-CSF-mobilized peripheral blood stem cells from donors were collected and transplanted into patients. GVHD prophylaxis with CSA and short-term methotrexate. Administer CSA 3 mg / kg / d by continuous intravenous infusion on day -1 and switch to oral administration on day 14; CSA should be tapered and discontinued after 180 days without GVHD. Patients received methotrexate (15 mg / m2 / day) on day 1 after stem cell transplantation; methotrexate (10 mg / m2 / day) on ...

Embodiment 3

[0025] Embodiment three prevents infection

[0026] The patient lived in a single-person HEPA laminar flow ward. Infusion of leukocyte-depleted blood products to maintain hemoglobin level above 60 g / L and platelet count above 20×10 9 / L. From day -10 to day 90, acyclovir was given for herpes prophylaxis, and trimethoprim-sulfamethoxazole was given from day -10 to day 1 to prevent Pneumocystis carinii infection; Fungal infection prophylaxis with voriconazole from day -10 to day 90. All patients received ganciclovir (5 mg / kg / day) for prophylaxis of CMV infection on days -14 to -2. Granules of G-CSF were injected subcutaneously on day 3 until hematopoietic reconstitution. Recombinant human TPO was injected subcutaneously on day 3 until the platelets exceeded 100×10 9 / L.

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Abstract

The present invention provides a combination for treating high-risk acute myeloid leukemia. The combination comprises natural killer (NK) cells and hematopoietic stem cells from a same haploidenticaldonor, and is simultaneously, separately or sequentially applied to treat the high-risk acute myeloid leukemia. Graft-versus-host disease (GVHD) is prevented by inputting donor's NK cells before stemcell transplantation. By detecting patient's killer immunoglobulin-like receptor (KIR) and human leukocyte antigen (HLA) genes and donor's HLA gene, haploidentical property of the patient and donor'sHLA gene is determined, and mismatch of the patient's KIR and donor's HLA is determined. In the treatment, the combination can reduce recurrence of the high-risk acute myeloid leukemia after the hematopoietic stem cell transplantation and improves a cure rate.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a combination for treating high-risk acute myeloid leukemia, which comprises natural killer (NK) cells and hematopoietic stem cells derived from haploidentical donors. Background technique [0002] Allogeneic hematopoietic stem cell transplantation (HSCT) is a curative therapy for adults with acute myeloid leukemia. Human leukocyte antigen (HLA) haploidentical hematopoietic stem cell (haplo-HSCT) transplantation has resolved the donor scarcity problem requiring transplantation with an HLA-identical donor. The overall survival rate of haplo-HSCT transplantation for acute myeloid leukemia is about 40%-60%. However, the high recurrence rate after stem cell transplantation is the main reason affecting its curative effect. Therefore, preventing relapse after stem cell transplantation may improve overall survival of patients. Natural killer (NK) cells are an importan...

Claims

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Application Information

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IPC IPC(8): A61K35/17A61K35/28A61P35/02
CPCA61K35/17A61K35/28A61P35/02A61K2300/00
Inventor 张明杰
Owner SHENZHEN HANK BIOLOG ENG CO LTD
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