Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Cyclophosphamide

Diphenhydramine

Promethazine

Cimetidine

Pretreatment：patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment.

NK cells infusion：30-60 minutes before infusion，ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10\^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10\^9 cells. 4 hours after NK cells infusion，IL-2 is applied every other day for six times

NK cells infusion

Yueyin Pan, PhD

Wei Wang, MD

Yue-Yin Pan, PhD

This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients

NK Cells Infusion for Advanced Malignancies

A Clinical Research of Natural Killer (NK) Cells Infusion for the Treatment of Advanced Malignant Tumor

CD56 positive cells ≥100 cells/μL in blood is considered as successful expansion of NK cells

The percentage of patients who reach complete response（CR）or partial response （PR）after all treatment finished. The response is evaluated according to irRECIST.

The interval time from the date when patients are enrolled into study to death or the last visit

The interval time from the date when patients are enrolled into study to disease progression, death or last visit

Numbers of CD56 positive cell in peripheral blood

Anhui Provincial Hospital

Professor of Department of Medical Oncology

Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid, Acute

Neoplasm, Residual

Leukemia, Myeloid

Neoplasms by Histologic Type

Hematologic Diseases

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Immunomodulating Agents

Immunosuppressive Agents

NK cells infusion after immunosuppressive chemotherapy

NK cells

Roberto M Lemoli, MD

Antonio Curti, MD

AML patients with de-novo or secondary disease with age greater than 18 years not eligible for stem cell transplantation for medical contraindications, lack of donor or lack of stem cells,are eligible. Leukemias other than AML and M3 FAB subtype will be excluded from the study. Immunosuppressive chemotherapy prior to NK cell infusion will include: fludarabine and cyclophosphamide 4g/m2 (Flu/Cy). The therapy will be administered over 6 days on inpatient basis. Haploidentical NK cells will be selected from a steady-state large volume leukapheresis product from a suitable KIR ligand incompatible donor. Donor-recipients pairs will be selected on the basis of known KIR ligands. In particular, haploidentical donors will be included if present at least one allele mismatch at a class I locus among the following ones: HLA-C alleles with Asn77-Lys80, HLA-C alleles with Ser77-Asn80, HLA-Bw4 alleles. Immunomagnetic enrichment of NK cells will follow two subsequent steps: 1) depletion of CD3+ T cells followed by 2) positive selection of CD56+ NK cells. Contaminating CD3+ T cells will be carefully evaluated.

When previously cryproserved NK cells are still available, further re-infusions may be performed, according to PI's evaluation. The number of remaining NK cells must be sufficient for the reinfusion of at least the minimum dose of cells (106/kg). At least two months should elapse between two consecutive infusion procedures.

Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells

University of Bologna

prof. Roberto M. Lemoli

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
NK Cells Infusion for Advanced Malignancies	NCT03619954	Immunotherapy	NK cells infusi...	18 Years - 75 Years	Anhui Provincial Hospital
Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells	NCT00799799	Myeloblastic Le...	NK cells	18 Years -	University of Bologna

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