IC14 for ALS Patients Expanded Access
NCT04309604 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2025-08-20
Summary
The primary objective is to provide the investigational product, IC14, at the dose of 8 mg/kg intravenously every 2 weeks for 12 weeks to 6 participants with amyotrophic lateral sclerosis (ALS). No clinical hypotheses are being tested. An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.A second extension for 14 doses every 2 weeks will be allowed if the drug is safe and well tolerated.
Conditions
Interventions
- BIOLOGICAL
-
IC14
monoclonal antibody directed against CD14
Sponsors & Collaborators
-
Massachusetts General Hospital
collaborator OTHER -
Implicit Bioscience
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
More Related Trials
-
A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)
NCT07290062 ·Status: RECRUITING ·Phase: PHASE1
-
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT00424463 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
NCT01492686 ·Status: COMPLETED ·Phase: PHASE3
-
Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS
NCT01759784 ·Status: WITHDRAWN ·Phase: PHASE1
-
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
NCT00415519 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Exploratory Efficacy Study of Intrathecally Administered Gene Therapy AMT-162 in Adult Participants With SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS)
NCT06100276 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
NCT03268603 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
NCT02492516 ·Status: COMPLETED ·Phase: PHASE1
-
Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)
NCT01142856 ·Status: COMPLETED ·Phase: PHASE1
-
Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS
NCT01759797 ·Status: COMPLETED ·Phase: PHASE1
-
Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS
NCT01771640 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis
NCT01609283 ·Status: COMPLETED ·Phase: PHASE1
-
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
NCT05176093 ·Status: COMPLETED ·Phase: PHASE2
-
HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262
NCT05740813 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS
NCT06598202 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Tolerability and Efficacy of ILB in Patients With Amyotrophic Lateral Sclerosis
NCT03613571 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Extension Study of TRO19622 in ALS
NCT01285583 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Metagenomic Characterization of the Intestinal Microbiota in ALS Patients and Association With Clinical Phenotypes
NCT06771414 ·Status: NOT_YET_RECRUITING
-
Determining the Safety of L-serine in ALS
NCT01835782 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose
NCT05136885 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS
NCT05003921 ·Status: SUSPENDED ·Phase: PHASE1
-
A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS)
NCT06910384 ·Status: TERMINATED ·Phase: PHASE2
-
Single-Ascending-Dose Safety/Tolerability of NP001 in Amyotrophic Lateral Sclerosis (ALS)
NCT01091142 ·Status: COMPLETED ·Phase: PHASE1
-
Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)
NCT01640067 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS)
NCT03168711 ·Status: COMPLETED ·Phase: PHASE2