A Clinical Pharmacological Study of MT-3921 in Subjects with HAM

JRCT ID: jRCT2031210616

Registered date:18/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy (HAM)
• Date of first enrollment: 02/05/2022
• Target sample size: 15
• Study type: Interventional
• Intervention(s): MT-3921 or placebo will be administered intravenously.

Outcome(s)

Primary Outcome

Percentage of subjects with adverse events
Percentage of subjects with adverse reactions
Serum concentrations of MT-3921
CSF concentrations of MT-3921

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Additional screening criteria check may apply for qualification:
- Subjects aged 20 years or older on the day of consent
- Subjects with a confirmed diagnosis of HAM according to the diagnostic algorithm of Practical Guideline for HAM 2019 on the day of consent
- Subjects with an Osame's motor disability score (OMDS) of >=4 and =<6 at Screening and on the first day of the Treatment period (predose)
- Subjects with no change in OMDS for at least 3 months before the day of consent
- Subjects with a CSF concentration neopterin of >=6 pmol/mL at Screening
-Subjects on maintenance oral steroid therapy who have continued to receive the same dose equivalent to =<10 mg/day of prednisolone for at least 3 months before the day of consent

Exclude criteria

Additional screening criteria check may apply for qualification:
- Subjects who have a history of anaphylaxis or clinically significant allergic reactions due to administration of antibody products
- Subjects exhibiting or with a history of malignant tumor.
- Subjects with adult T-cell leukemia/lymphoma (ATL) or those with positive HTLV-1 clonality test (Southern blot) at screening and suspected of having ATL
- Subjects with spinal cord compression lesions, such as cervical spine disease, disc herniation, and ossification of the yellow ligament
- Subjects with psychiatric disorders, epileptic seizures, or dementia.
- Subjects with suicide attempts or suicidal ideation corresponding to item 4 or 5 on the Columbia Suicide Rating Scale (C-SSRS) at screening and/or on the first day of the Treatment period (predose)
- Subjects exhibiting or with a history of hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
- Subjects with the novel Coronavirus disease 2019 (COVID-19)
- Subjects with severe illness
- Male or female subjects of childbearing potential who do not agree to use a contraceptive measure from the day of consent to 16 weeks after the last dose of the investigational medical product
- Female subjects who are pregnant, lactating, or may be pregnant
- Subjects who have received anti-repulsive guidance molecule (RGM) a antibody containing this investigational medical product
- Subjects who participated in other clinical studies (including clinical trials) and received drugs (including investigational medical products) or therapy within 12 weeks before the day of consent

Related Information

• Primary Sponsor: Kazuoki Kondou
• Secondary ID(s): NCT05240612