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Prosthetic Joint Infections of HipPhase 2NCT06621251

Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection

A Phase 2 study testing TRL1068 (calpurbatug), a human monoclonal antibody and DAIR in people with Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee, run by Trellis Bioscience LLC at 11 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
TRL1068 (calpurbatug), a human monoclonal antibody and DAIR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
11 sitesUnited States
Study dates
8 Apr 2025to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 85 years, inclusive
  • Chronic PJI:
  • Systemic Host Grade of A or B [McPherson 2011] (Appendix 3) and either
  • First chronic PJI of the hip or knee, confirmed by synovial fluid aspirate culture or
  • Recurrent chronic PJI of the hip or knee confirmed by synovial fluid aspirate culture
  • Willing to be randomized to either:
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  • Receive TRL1068 and to be scheduled for DAIR between Day 15 + 7 days (i.e., between days 15-22) and 10 weeks of targeted antibiotic treatment or
  • Participate in an observational study arm that receives SoC (i.e., two-stage prosthetic joint replacement) and
  • Sonication of the explanted prosthesis and performance of synovial fluid aspirates ii. Consents to conduct of stage 2 (implantation of new prosthesis)
  • At least 1 positive bacterial culture without concomitant fungal infection from the infected joint (a joint aspirate within 28 days prior to Screening is acceptable)
  • All identified pathogen(s) are susceptible to the planned antibiotic regimen
  • Availability of radiology assessments of the affected joint without signs of loosening of the prosthesis or presence of osteomyelitis
  • Willing and able to provide written informed consent
  • Willing to perform and comply with all study procedures, including attending clinic visits as scheduled
  • Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) through Day 365.

Who cannot join

  • PJI associated with presence of concomitant fungal infection or bacterial pathogens that, even when in planktonic form (i.e., when released from biofilm), cannot be adequately treated with available antibiotics.
  • More than one draining sinus and single draining sinus of > 1 cm
  • Less than 3 years life expectancy based on underlying morbidities
  • Expected to receive chronic suppressive antibiotic therapy
  • Congestive heart failure; New York Heart Association (NYHA) Functional Classification of Heart Failure Grade > 3B
  • Uncontrolled diabetes, defined as hemoglobin A1c > 7.4%.
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  • BMI > 45
  • Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation of TRL1068, especially local or systemic fungal and other known or suspected bacterial infections
  • Receiving or recently received another investigational drug (within 30 days of Day 1, or 5 half-lives of the investigational drug, whichever is longer)
  • Received any vaccine within 14 days prior to Day 1
  • Positive serum pregnancy test for WOCBP, or nursing women
  • History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with all study requirements
  • Any other comorbidity or condition that, in the opinion of the Investigator would make the patient unsuitable for the study or unable to comply with the study requirements.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Sinai Hospital Baltimore

    Baltimore, Maryland, 21215

  • New England Baptist Hospital

    Boston, Massachusetts, 02120

  • OrthoArizona

    Gilbert, Arizona, 85234

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • UCLA

    Los Angeles, California, 90024

  • University of Rochester

    Rochester, New York, 14623

  • North Texas Medical Research Institute

    Rockwall, Texas, 75087

  • University of Utah

    Salt Lake City, Utah, 84112

  • Gulfcoast Research Institute

    Sarasota, Florida, 34232

  • Phoenix Clinical Research

    Tamarac, Florida, 33321

  • M3 Wake Research Associates

    Wilmington, North Carolina, 28412

Other trials in United States

About this study

Official title: Phase 2 Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Chronic Prosthetic Joint Infection of the Knee or Hip Without Exchange Arthroplasty

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR (debridement, antibiotics, and implant retention) procedure for chronic prosthetic joint infections of the knee and hip, specifically, eliminating the need for the standard of care 2-stage exchange surgery, so that the original prosthesis can be retained.

Read the detailed description

Approximately 75% of all clinically significant human infections are estimated to be biofilm-related. Prosthetic joint infections are a classical example of difficult to eradicate infections associated with biofilm. Most Prosthetic Joint Infection (PJI) cases are caused by staphylococcal species (~70%) with an increasing number being antibiotic-resistant (MRSA). In the US, two-stage revision is the standard of care for replacement of an infected prosthetic joint, and is associated with substantial costs and prolonged immobility. TRL1068 is a fully human antibody that has been shown in pre-clinical studies and in the first-in-human Phase 1 study TRL1068-101 to disrupt biofilm. TRL1068 targets a highly conserved epitope on the DNABII family of bacterial DNA binding proteins that includes histone-like (HU) and integration host factor (IHF) proteins of clinically relevant Gram-positive and Gram-negative bacteria. The DNABII epitope bound by TRL1068 has no homologs in the human proteome.

Being tested
TRL1068 (calpurbatug), a human monoclonal antibody, DAIR
Keywords
biofilm, antibiotic-resistant infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRL1068 (calpurbatug), a human monoclonal antibodyDrug

    A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody

  • DAIRProcedure or surgery

    Also called debridement, antibiotics, and implant retention

    DAIR procedure will be performed between days 15-22

Study groups in NCT06621251
Study groupRoleWhat they receive
TRL1068 + DAIRExperimentalTRL1068 will be administered at 15 mg/kg IV on Day 1 and subsequently at 7.5 mg/kg on Days 15, 29, and 43. Between Day 15-22, a DAIR procedure will be completed.
Receives: Drug: TRL1068 (calpurbatug), a human monoclonal antibody; Procedure: DAIR
SoCNo interventionStandard of Care arm, receiving 2-stage surgery as is SoC for PJI. Reduced assessments will be done at the same timepoints as the experimental arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of TRL1068 in eliminating the need for an SoC 2-stage exchange arthroplasty

    Incidence of resolved PJI, i.e., completion of planned surgical interventions for PJI (DAIR or 2-stage exchange arthroplasty), and not receiving systemic antibiotics for PJI or antibiotic suppression therapy for PJI or any other planned interventions to treat PJI by end of study.

    Measured: Day 365

Secondary outcomes (9)

  1. Duration (days) with resolved PJI

    Days after completion of planned surgical interventions for PJI (DAIR or 2-stage exchange arthroplasty) without receiving systemic antibiotics for PJI or antibiotic suppression therapy of PJI or any other planned interventions to treat PJI by end of study.

    Measured: Day 365

  2. Incidence of recurrent PJI across treatment groups

    Recurrent PJI will include PJI in which the causative pathogen of the recurrent PJI was not identified at baseline.

    Measured: Day 365

  3. Incidence of PJI reinfection across treatment groups

    Measured: Day 365

  4. Incidence, duration and severity of AEs or SAEs of secondary infections

    Measured: Day 365

  5. Musculoskeletal Infection Society (MSIS) Scores

    MSIS scores on Day 1, day of DAIR (Day 15 + 7 days) versus Day 1, day of first stage of SoC and EOS (Day 365) that are indicative of the presence of PJI. MSIS Minor Criteria score range is 0-12, above or equal to 6 is infected, 2-5 is possibly infected, 0-1 is not infected.

    Measured: Day 365

  6. Quality of life PROMIS-PF Short Form 6b

    Quality of life as measured by the Quality of Life (QoL) Questionnaire (PROMIS-PF Short Form 6b). Score range is 6-30, with higher scores indicating higher functioning.

    Measured: Day 365

  7. Resource utilization: duration of hospitalization as a result of PJI, SoC or surgical wound infection

    Measured: Day 365

  8. Resource utilization: need to stay in a rehabilitation center or other institution, e.g., nursing home as a result of PJI, SoC or surgical wound infection

    Measured: Day 365

  9. Incidence, duration and severity of AEs and SAEs across treatment groups

    abnormal vital signs and safety labs will be documented as adverse events.

    Measured: Day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start8 Apr 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06621251
Sponsor's protocol ID
TRL1068-201
Status last verified
May 2026
First submitted
26 Sep 2024
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The study results will be published after the study is completed.

Publications

  • Conway J, Delanois RE, Mont MA, Stavrakis A, McPherson E, Stolarski E, Incavo S, Oakes D, Salvagno R, Adams JS, Kisch-Hancock A, Tenorio E, Leighton A, Ryser S, Kauvar LM, Bernthal NM. Phase 1 study of the pharmacokinetics and clinical proof-of-concept activity of a biofilm-disrupting human monoclonal antibody in patients with chronic prosthetic joint infection of the knee or hip. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0065524. doi: 10.1128/aac.00655-24. Epub 2024 Jul 16.

    PubMed 39012102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TRL1068 (calpurbatug), a human monoclonal antibody and DAIR in people with Prosthetic Joint Infections of Hip and Prosthetic Joint Infections of Knee, run by Trellis Bioscience LLC at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of TRL1068 in eliminating the need for an SoC 2-stage exchange arthroplasty (time frame: Day 365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06621251, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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