← Back to Search

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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 more

Secondary 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 more

Other outcome measures

Inflammation

Exploratory outcome measure to assess quality of life

Exploratory outcome measure to determine CFUs

+5 more

Trial 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

0 / 3Eligibility criteria met

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

TRL1068 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04763759 — Phase 1

Prosthetic Joint Infections Research Study Groups: Dose Level 3- 30 mg/kg, Dose Level 2- 15mg/kg, Dose Level 1- 6mg/kg

Prosthetic Joint Infections Clinical Trial 2023: TRL1068 Highlights & Side Effects. Trial Name: NCT04763759 — Phase 1

TRL1068 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763759 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare centers are hosting this clinical investigation?

"Currently, 4 sites are running this trial. Participants can choose from Tamarac, Baltimore and Santa Monica or any of the other available locations for easier access to medical care."

Answered by AI

Am I eligible to participate in this experimental research?

"For eligibility, individuals must be aged 18-85 and have an infection. With 28 places available, this medical trial is open to applicants that meet these criteria."

Answered by AI

Does TRL1068, a human monoclonal antibody, present any risk to those taking part in the trial?

"Given the limited clinical data surrounding TRL1068, a human monoclonal antibody, our team has assigned it a safety score of 1. This is in keeping with Phase 1 trial expectations as efficacy and safety are still being evaluated."

Answered by AI

What is the intended outcome of this experiment?

"This 16-week trial will primarily monitor the Incidence of Abnormal Vital Signs (Heart Rate). Secondary objectives involve measuring the pharmacodynamics (PD) of TRL1068, including its Inflammatory biomarkers ESR and CRP. Furthermore, ELISA tests shall be used to measure serum and synovial concentrations of TRL1068 on Day 8."

Answered by AI

Is it still possible to register for this research initiative?

"Per the details on clinicaltrials.gov, this experiment is actively recruiting individuals. It was first advertised on February 8th 2021 and recently updated July 5th 2022."

Answered by AI

What is the aggregate participant count for this experiment?

"That is correct. According to the data posted on clinicaltrials.gov, this research endeavour initially went live on February 8th 2021 and was last updated July 5th 2022. 28 individuals have been targeted for recruitment across 4 different sites."

Answered by AI

Does this research project accept participants younger than age 55?

"According to the criteria of this trial, potential participants must be aged 18 years or older and no more than 85."

Answered by AI

Who else is applying?

What site did they apply to?

Sinai Hospital of Baltimore

Houston Methodist Research Institute

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I am on suppression antibiotics my infection is from pseudomonas aeruginosa and they tell me that there is nothing else that can be done and the next step would be amputation.i had three revision surgeries and had extensive repair of the soft tissue by a plastic surgery and he told me I couldn’t have anymore surgery on it. Trying a new drug is about all I can do.

PatientReceived no prior treatments

Recent research and studies

Antimicrobial Agents and ChemotherapyJournal

A Human Biofilm-disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of Both Staphylococcus Aureus and Acinetobacter Baumannii Infections

Xiong, Yan Q., Angeles Estellés, L. Li, W. Abdelhady, R. Gonzales, Arnold S. Bayer, Edgar Tenorio, Anton Leighton, Stefan Ryser, and Lawrence M. Kauvar. 2017. “A Human Biofilm-disrupting Monoclonal Antibody Potentiates Antibiotic Efficacy in Rodent Models of Both Staphylococcus Aureus and Acinetobacter Baumannii Infections”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.00904-17.

Antimicrobial Agents and ChemotherapyJournal

A High-affinity Native Human Antibody Disrupts Biofilm from Staphylococcus Aureus Bacteria and Potentiates Antibiotic Efficacy in a Mouse Implant Infection Model

Estellés, Angeles, Anne-Kathrin Woischnig, Keyi Liu, Robert Stephenson, Evelene Lomongsod, Da Nguyen, Jianzhong Zhang, et al.. 2016. “A High-affinity Native Human Antibody Disrupts Biofilm from Staphylococcus Aureus Bacteria and Potentiates Antibiotic Efficacy in a Mouse Implant Infection Model”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.02588-15.

clinicaltrials.govStudy

Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections

2021. "Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04763759.