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Monoclonal Antibodies
TRL1068 for Prosthetic Joint Infections
Phase 1
Waitlist Available
Led By Richard Berkowitz, MD
Research Sponsored by Trellis Bioscience LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned/scheduled for primary two-stage exchange arthroplasty
Identified pathogen(s) must be susceptible to antibiotic regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can make it easier to treat infections in people with artificial joints. The goal is to show that the drug can help a lot of people with this infection.
Who is the study for?
This trial is for adults with knee or hip prosthetic joint infections who are scheduled for a two-stage exchange arthroplasty, have a BMI under 40, and can follow the study plan. They must not have other active infections, recent cancers, autoimmune diseases, uncontrolled diabetes, significant heart or liver issues, drug/alcohol abuse history or be immunocompromised.Check my eligibility
What is being tested?
TRL1068 is being tested to see if it can break down biofilms protecting pathogens in infected joints making them more vulnerable to antibiotics. This first study looks at its safety and how the body processes it. The aim is to help patients keep their original prosthetic joint or successfully replace it.See study design
What are the potential side effects?
While specific side effects of TRL1068 aren't listed here as this is an initial study assessing safety and PK; generally monoclonal antibodies may cause allergic reactions, infusion-related symptoms like fever or chills, possible organ inflammation and increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a two-stage joint replacement surgery.
Select...
The bacteria causing my infection can be treated with antibiotics.
Select...
I have an infection in my knee or hip joint.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Abnormal Physical Examination Findings
Incidence of Abnormal Serum Chemistries and Hematology
Incidence of Abnormal Vital Signs (Blood Pressure)
+3 moreSecondary outcome measures
Assess the immunogenicity of TRL1068 as measured by anti-drug antibodies (ADAs)
Assess the pharmacodynamics (PD) of TRL1068 (CFUs spacer)
Assess the pharmacodynamics (PD) of TRL1068 (CRP)
+7 moreOther outcome measures
Inflammation
Exploratory outcome measure to assess quality of life
Exploratory outcome measure to determine CFUs
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Dose Level 3- 30 mg/kgExperimental Treatment1 Intervention
Randomized 5:2 (TRL1068:placebo) via IV infusion
Group II: Dose Level 2- 15mg/kgExperimental Treatment1 Intervention
Randomized 5:2 (TRL1068:placebo) via IV infusion
Group III: Dose Level 1- 6mg/kgExperimental Treatment1 Intervention
Randomized 3:1 (TRL1068:placebo) via IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TRL1068, a human monoclonal antibody
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Sinai Hospital of BaltimoreOTHER
7 Previous Clinical Trials
393 Total Patients Enrolled
Gulfcoast Research InstituteUNKNOWN
Phoenix Clinical ResearchOTHER
3 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a two-stage joint replacement surgery.I have received a biological therapy within the last 6 months.My heart test (ECG) results do not prevent me from having a specific joint surgery.My liver function is moderately to severely impaired.The bacteria causing my infection can be treated with antibiotics.I have an infection in my knee or hip joint.I am willing to follow all study rules and attend all clinic visits.I do not have any active infections, except possibly a bacterial infection in my knee or hip.I have had cancer or chemotherapy in the last 2 years.I have not been sick in the last 14 days.I am willing to use effective birth control.I am immunocompromised or taking high doses of corticosteroids.I cannot tolerate or take the usual antibiotics for my infection.I have been diagnosed with COPD.I have been diagnosed with congestive heart failure.You have experienced bad reactions or allergies to any biologic medications.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 3- 30 mg/kg
- Group 2: Dose Level 2- 15mg/kg
- Group 3: Dose Level 1- 6mg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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