Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)

Phase 1

• Conditions: HAM

• Registration Number: NCT02961712
• Lead Sponsor: The Second Affiliated Hospital of Fujian Medical University

Brief Summary

HTLV-1 Associated Myelopathy is a chronic disease of the spinal cord, caused by a virus called human T lymphotropic virus type 1（HTLV-1）. Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

Detailed Description

HAM is a chronic disease of the spinal cord, caused by a virus called HTLV-I. Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

In a single-center, one year open-label trial, 5 HAM patients will be treated with single intravenous injection of NK cells (0.9\~1\*10\^9). Then, the the clinical effect was evaluated by dynamic analysis of Osame's Motor Disability Score and other related physiological indices, such as HTLV-1 antibody titer in blood and cerebrospinal fluid.

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria

• HIV infection
• Hepatitis B & C viral infections
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change of Osame's Motor Disability Score	1 year	The score were defined as follows: 0, no disability; 1, walking slow; 2, a little trouble when walking; 3, unable to run; 4, needs guardrail while going up the stairs; 5, needs one hand support while walking; 6, needs two hands support while walking (\> 10 m); and 7, needs two hands support while walking (\< 10 m); 8, needs two hands support while walking (\< 5 m); 9, unable to walk but can crawl; 10, unable to crawl but can move; 11, unable to move but can roll over on the bed; 12 unable to roll over; 13, unable to flex toes

Secondary Outcome Measures

Name	Time	Method
HTLV-1 antibody titer in cerebrospinal fluid	1 year
HTLV-1 antibody titer in serum	1 year
HTLV-1 proviral load in blood	1 year

Trial Locations

Locations (1)

The Second Affiliated Hospital of Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China