Menu
Not yet recruiting NCT04662788

Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Early Phase I Interventional Hematological Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NK cells/Combined Monoclonal Antibodies.
Who it may be relevant to
Registry conditions: Hematological Malignancies. Basic parameters: 15 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Trial for the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Overview

Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies

Detailed description

This is a single arm, open-label, single-center study. This study is indicated for hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Interventions

  • Drug NK cells/Combined Monoclonal Antibodies
    Each subject receive NK cells/Combined Monoclonal Antibodies

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Baseline up to 28 days after NK cells/Combined Monoclonal Antibodies infusion]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after NK cells/Combined Monoclonal Antibodies infusion]
Secondary outcome measures (7)
  • Acute Myeloid Leukemia (AML), Overall response rate (ORR) [Time frame: At Month 1, 3, 6, 12, 18 and 24]
  • AML, Overall survival (OS) [Time frame: Up to 2 years after NK cells infusion]
  • AML, Event-free survival (EFS) [Time frame: Up to 2 years after NK cell/ Combined Monoclonal Antibodies infusion]
  • Quality of life [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Activities of Daily Living (ADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Instrumental Activities of Daily Living (IADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Hospital Anxiety and Depression Scale (HADS) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
  • Relapsed or refractory AML (meeting one of the following conditions):
  • CR not achieved after standardized chemotherapy;
  • CR achieved following the first induction, but CR duration is less than 12 months;
  • Ineffectively after first or multiple remedial treatments;
  • 2 or more relapses;
  • The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  • No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Exclusion criteria

  • History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
  • Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
  • Pregnant (or lactating) women;
  • Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
  • Previously treated with any CAR-T cell product or other genetically- modified T cell therapies;
  • Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;
  • Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT04662788 · NK-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗