A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
NCT06453668 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-03-31
Summary
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
Conditions
Interventions
- BIOLOGICAL
-
TCD601
Investigational Product
Sponsors & Collaborators
-
ITB-Med LLC
lead INDUSTRY
Principal Investigators
-
Fredrik Julin · ITB-Med LLC
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-16
- Primary Completion
- 2029-11-30
- Completion
- 2029-11-30
Countries
- Sweden
Study Locations
More Related Trials
-
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
NCT06740526 ·Status: RECRUITING ·Phase: PHASE2
-
An IIT Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Single Intrathecal Injection of SNUG01 in Patients with Amyotrophic Lateral Sclerosis
NCT06645197 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
NCT02245867 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT03861481 ·Status: COMPLETED ·Phase: PHASE2
-
Alemtuzumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD)
NCT01757574 ·Status: WITHDRAWN ·Phase: PHASE4
-
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT05327114 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
NCT05271409 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Anti-IL-6R mAb Injection in Patients With iMCD
NCT05345522 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Electrical Prognostic Factors of Response to Intravenous Immunoglobulin Treatment in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT03967899 ·Status: COMPLETED
-
Phase 1 Single Ascending Dose Study
NCT06934941 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Mirikizumab in Healthy Participants
NCT04607733 ·Status: COMPLETED ·Phase: PHASE1
-
Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)
NCT04589299 ·Status: RECRUITING ·Phase: PHASE4
-
Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
NCT06373211 ·Status: RECRUITING ·Phase: PHASE2
-
InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT04529291 ·Status: WITHDRAWN ·Phase: NA
-
Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
NCT04561557 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
NCT04025632 ·Status: TERMINATED ·Phase: PHASE2
-
Safety, Tolerability, and Efficacy of NVG-2089 in Participants With CIDP
NCT07027111 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT00001287 ·Status: COMPLETED ·Phase: PHASE2
-
Tofacitinib in Patients With Amyotrophic Lateral Sclerosis
NCT06689982 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
A Phase 3 Study of NTLA-2001 in ATTRv-PN
NCT06672237 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)
NCT05063162 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT06920004 ·Status: RECRUITING ·Phase: PHASE3
-
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
NCT07284797 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT04051944 ·Status: COMPLETED ·Phase: PHASE2
-
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT02465359 ·Status: COMPLETED ·Phase: NA