A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients

Phase 1RecruitingNCT06453668

ITB-Med LLC48 enrolled

Overview

The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.

The purpose of this study is to investigate how safe and tolerable the study drug siplizumab is when given to adult patients with ALS. The study will examine how the drug is distributed in the body and what effects it has on different immune cells in the blood and in the fluid surrounding the motor neurons (cerebrospinal fluid). In addition, the study will monitor the progression of ALS and look for any changes related to the disease that may occur during the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

ALS

Interventions

TCD601BIOLOGICAL

Investigational Product

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Male or female patients ≥ 18 to 80 years of age. * Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms. * Patients on existing ALS treatment must have been on a stable dose for 28 days. Key Exclusion Criteria: * Patient with severe systemic infections, current or within the two weeks prior to randomization. * Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol. * Use of other investigational products or treatment in another investigational drug study within 30 days of screening * Pregnant or nursing (lactating) women.

Locations (3)

Skåne University Hospital Malmö

Malmo, Sweden

RECRUITING

Studieenheten Akademiskt Specialistcentrum

Stockholm, Sweden

RECRUITING

Umeå University Hospital

Umeå, Sweden

RECRUITING

Outcomes

Primary Outcomes

Evaluation of the safety of TCD601 in adult patients with ALS

Assess the incidence of treatment-emergent Adverse Events \[Safety and Tolerability\]

Time frame: 12 Months

Secondary Outcomes

Evaluation of the pharmacokinetics (PK)

Siplizumab concentration over time

Time frame: 12 Months

Correlation of ALS disease status with leucocyte phenotypic profiles

The ALS disease status measured by ALSFRS and Kings staging will be compared with the leucocyte phenotypes measured by FACS analysis.

Time frame: 12 Months

Evaluation of levels of biomarkers

Neurofilament light chain levels over time

Time frame: 12 Months

Length of time from trial entry to tracheostomy / death

The time from study enrollment to patient death or tracheostomy will be measured.

Time frame: 12 Months

Assessment of clinically relevant changes in laboratory measurements

Incidence of abnormal laboratory values

Time frame: 12 Months

Evaluation of pharmacodynamics (PD) of TCD601

Lymphocyte counts by subset over time

Time frame: 12 Months

Assessment of clinically relevant changes in vital signs

Incidence of abnormal vital signs

Time frame: 12 Months

Central Contacts

Fredrik Juhlin

CONTACT

+46 (0)76 394 9872 fredrik.juhlin@itb-med.com

Data from ClinicalTrials.gov

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