Menu
Recruiting NCT07564154

A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)

Phase I Interventional Rheumatoid Arthritis (RA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KT502.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT502 by Subcutaneous Administration in Adult Participants With Rheumatoid Arthritis

Overview

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT502 administered subcutaneously to participants with Rheumatoid Arthritis (RA). The study will have 2 parts: Part A is a single ascending dose finding (SAD) and Part B is dose escalation by fractionated dosing.

Interventions

  • Drug KT502
    KT502 is a monoclonal antibody that depletes B cells by targeting CD19 and CD3

Primary outcome measures

  • Incidence of Adverse Events [Time frame: From Baseline Up to 12 weeks]
  • Incidence of Cytokine-release Syndrome (CRS) [Time frame: From Baseline Up to 12 Weeks]
  • Changes in Pulse Rate from Baseline [Time frame: From Baseline Up to 12 Weeks]
  • Changes in Respiratory Rate from Baseline [Time frame: From Baseline to 12 Weeks]
  • Changes in Blood Pressure from Baseline [Time frame: Baseline to 12 Weeks]
  • Changes in Temperature from Baseline [Time frame: Baseline to 12 Weeks]
  • Changes in Hematology Clinical Laboratory Results from Baseline [Time frame: From Baseline Up to 12 Weeks]
  • Changes in Chemistry Clinical Laboratory Results from Baseline [Time frame: From Baseline Up to 12 Weeks]
  • Changes in Urinalysis Clinical Laboratory Results from Baseline [Time frame: Baseline Up to 12 Weeks]
  • Changes in Coagulation Clinical Laboratory Results from Baseline [Time frame: From Baseline Up to 12 Weeks]
Secondary outcome measures (12)
  • Serum Concentrations of KT502 [Time frame: Part A: Pre-dose; Day 2, 3, 8, 15, 29 Part B (1st Dose): Pre-dose, Day 2, 3 Part B (2nd Dose): Pre-dose Day 8; Day 9, 10, 11, 15, 29, 43, 57 and 85]
  • Incidence of Treatment-induced Anti-Drug Antibodies (ADAs) [Time frame: Part A: Pre-dose; Day 8, 15, 22, 29, 43, 57 and 85 Part B (1st Dose): Pre-dose Part B (2nd Dose): Pre-dose Day 8; Day 11, 15, 22, 29, 43, 57 and 85]
  • To Determine Cmax [Time frame: Day 1 - Day 85]
  • To Determine Tmax, Derived from Serum Concentration of each Dose of KT502 [Time frame: Day 1 - Day 85]
  • Area Under the Serum-concentration Time Curve (AUC) from Time Zero to the Last Timepoint with Measurable Analyte Concentration (AUC0-t) [Time frame: Day 1 - Day 85]
  • AUC from Time Zero to Infinity (AUCinf) [Time frame: Day 1 - Day 85]
  • To Determine Terminal Half-Life (T1/2) [Time frame: Day 1 - Day 85]
  • Total Body Clearance (CL/F) [Time frame: Day 1 - Day 85]
  • Volume of Distribution During the Terminal Phase (Vz/F) [Time frame: Day 1 - Day 85]
  • Change in Levels of B Cell Count [Time frame: Screening; Day 1 - Day 85]
  • Duration of B Cell Depletion [Time frame: Day 1 - Day 85]
  • Change in Levels of Acute Inflammatory Markers [Time frame: Pre-dose; Day 2, 3, 4, 5, 8, 9, 10, 15, 22, 29, 43, 57 and 85]

Eligibility criteria

Inclusion:

  • 18 to 75 years old
  • Diagnosis of adult-onset RA for at least 6 months
  • Moderately to severely active RA
  • Inadequate treatment response as defined in the protocol
  • RF + or ACPA+
  • Stable use of traditional DMARDs is permitted
  • Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Exclusion:

  • Functional class IV as defined by the ACR Classification of Functional Status in RA
  • Presence of any concomitant autoimmune disease other than RA
  • Active infection, history of serious recurrent or chronic infection
  • History of progressive multifocal leukoencephalopathy
  • Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years.
  • History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
  • Receipt of live vaccine within 4 weeks
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study
  • Women who are pregnant or breastfeeding
  • Significant or uncontrolled medical disease that would preclude participant participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Kali Therapeutics Trial Site — Bayswater
New Zealand · 1 center
  • Kali Therapeutics Trial Site — Auckland

Identifiers

NCT: NCT07564154 · KT502-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗