Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07564154

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kali Therapeutics Trial Site, Bayswater, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KT502

Drug

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

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: From Baseline Up to 12 weeks

    Incidence and severity of Adverse Events, including DLTs, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  2. Incidence of Cytokine-release Syndrome (CRS)

    Time frame: From Baseline Up to 12 Weeks

    Incidence and severity of CRS with severity determined according to the 2019 American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus grading criteria

  3. Changes in Pulse Rate from Baseline

    Time frame: From Baseline Up to 12 Weeks

    Vital signs: Changes in Pulse Rate from Baseline

  4. Changes in Respiratory Rate from Baseline

    Time frame: From Baseline to 12 Weeks

    Vital Signs: Changes in Respiratory Rate from Baseline

  5. Changes in Blood Pressure from Baseline

    Time frame: Baseline to 12 Weeks

    Vital Signs: Changes in Blood Pressure from Baseline

  6. Changes in Temperature from Baseline

    Time frame: Baseline to 12 Weeks

    Vital Signs: Changes in Body Temperature from Baseline

  7. Changes in Hematology Clinical Laboratory Results from Baseline

    Time frame: From Baseline Up to 12 Weeks

    Hematology: Changes in results from Baseline

  8. Changes in Chemistry Clinical Laboratory Results from Baseline

    Time frame: From Baseline Up to 12 Weeks

    Chemistry: Changes in results from Baseline

  9. Changes in Urinalysis Clinical Laboratory Results from Baseline

    Time frame: Baseline Up to 12 Weeks

    Urinalysis: Changes in results from Baseline

  10. Changes in Coagulation Clinical Laboratory Results from Baseline

    Time frame: From Baseline Up to 12 Weeks

    Coagulation: Changes in results from Baseline

  11. ECG

    Time frame: From Baseline to 12 Weeks

    Change from baseline in 12-lead electrocardiogram (ECG)

Secondary outcomes

  1. 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

    Blood samples will be collected at specific time points for calculating serum concentrations of KT502

  2. 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

    Immunogenicity: Incidence of participants with treatment induced Anti-Drug Antibodies (ADA)

  3. To Determine Cmax

    Time frame: Day 1 - Day 85

    Maximum observed serum KT502 concentration

  4. To Determine Tmax, Derived from Serum Concentration of each Dose of KT502

    Time frame: Day 1 - Day 85

    Time to maximum observed concentration

  5. 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

    Area under the concentration-time curve from 0 to the time of the last quantifiable concentration (AUClast)

  6. AUC from Time Zero to Infinity (AUCinf)

    Time frame: Day 1 - Day 85

    Area under the plasma concentration versus time curve (AUC) from time 0 extrapolated to infinity

  7. To Determine Terminal Half-Life (T1/2)

    Time frame: Day 1 - Day 85

    Terminal elimination half-life summarized by dosing regimen

  8. Total Body Clearance (CL/F)

    Time frame: Day 1 - Day 85

    CL is the measure of the rate at which a drug is metabolized or eliminated by normal biological processes

  9. Volume of Distribution During the Terminal Phase (Vz/F)

    Time frame: Day 1 - Day 85

    Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug

  10. Change in Levels of B Cell Count

    Time frame: Screening; Day 1 - Day 85

    Pharmacodynamics: Change in levels of B cell counts measured at specific timepoints

  11. Duration of B Cell Depletion

    Time frame: Day 1 - Day 85

    Pharmacodynamics: The duration of B cell depletion measured from Baseline

  12. 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

    Pharmacodynamics: Change in levels of acute Inflammatory markers (C-reactive protein (CRP) and CRS-related cytokines at specific timepoints

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Information

CONTACT

[email protected]

1-858-888-3080

Sponsors and collaborators

Lead sponsor

Kali Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.