Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease

NCT04209712 | Unknown Early Phase 1

• 1 other identifier: DS2019070101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Minimal Residual Disease (MRD)

  MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.

  12 months

Secondary Outcomes (1)

• Number of participants with adverse events

  12 months

Study Arms (1)

haploid allogeneic NK cell therapy

EXPERIMENTAL

haploid allogeneic NK cell therapy with chemotherapy

Biological: haploid allogeneic NK cell therapy

Interventions

haploid allogeneic NK cell therapy BIOLOGICAL

NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.

haploid allogeneic NK cell therapy

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with acute myeloid leukemia;
• MRD after 2 course of standard chemotherapy;
• No plan for hematopoietic stem cell transplantation;
• Hemoglobin (Hb) \>=60g/L, white blood cell count (WBC) \>=2.5x10\^9/L, platelet count \>=30x10\^9/L;
• Patients have self-knowledge ability and can sign informed and voluntary consent forms;
• Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study.

You may not qualify if:

• Intracranial hypertension or unconsciousness;
• Symptomatic heart failure or severe arrhythmia;
• Respiratory failure;
• With other types of malignant tumor diseases;
• T lymphocytic acute leukemia;
• Diffuse intravascular;
• Serum creatinine and / or urea nitrogen \>=1.5 times the normal value;coagulation;
• Serum total bilirubin \>=1.5 times the normal value;
• Sepsis or other difficult-to-control infections;
• Uncontrollable diabetes;
• severe mental disorders;
• WHO physical status classification \>=3;
• People who are allergic to Interleukin-2;
• Patients after organ transplant;
• Pregnant and lactating women.

Sponsors & Collaborators

• Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China: lead
• Hebei Yanda Ludaopei Hospital: collaborator

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, 065201, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xian Zhang

  Hebei Yanda Ludaopei Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang ZHU

CONTACT

+86-15900398802; zhujiang@icell.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: haploid allogeneic NK cell therapy with chemotherapy

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

CN (1)