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Rheumatoid Arthritis (RA)Phase 1NCT07234773

A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).

A Phase 1 study testing KT501 in people with Rheumatoid Arthritis (RA), run by Kali Therapeutics, Inc. at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
KT501
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteAustralia
Study dates
6 Mar 2026to Aug 2027
Phase
Phase 1
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Trial Information contact

1-858-888-3080

clinical@kalitherapeutics.com

Australia1 site, 1 recruiting

  • Kali Study Site

    Bayswater

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 1a, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT501 by a Single Subcutaneous Administration in Participants With Rheumatoid Arthritis

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA).

Read the detailed description

This is a Phase 1, open-label, first-in-human dose escalation study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic of KT501 by a single subcutaneous administration in participants with Rheumatoid Arthritis (RA).

Up to a total of 5 cohorts with up to approximately 24 participants in total with RA will be enrolled. All participants will receive a single dose of KT501 on Day 1 and followed up until Week 12. For any participants with B cells lower than baseline level or lower limit quantification, whichever is lower, additional B cell follow up is required up to Week 48 after the study treatment.

Being tested
KT501
Keywords
Rheumatoid Arthritis (RA), Autoimmune, T-cell Engagers (TCEs), B-cell Depletion
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • KT501Drug

    KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.

Study groups in NCT07234773
Study groupRoleWhat they receive
Dose Level 1ExperimentalKT501 Subcutaneous Injection Dose Level 1
Receives: Drug: KT501
Dose Level 2ExperimentalKT501 Subcutaneous Injection Dose Level 2
Receives: Drug: KT501
Dose Level 3ExperimentalKT501 Subcutaneous Injection Dose Level 3
Receives: Drug: KT501
Dose Level 4ExperimentalKT501 Subcutaneous Injection Dose Level 4
Receives: Drug: KT501
Dose Level 5ExperimentalKT501 Subcutaneous Injection Dose Level 5
Receives: Drug: KT501

What is being measured

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

  1. Incidence of Adverse Events

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

    Measured: From Baseline Up to 12 weeks

  2. Incidence of Cytokine-release Syndrome (CRS)

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

    Measured: From Baseline Up to 12 Weeks

  3. Changes in Pulse Rate from Baseline

    Vital signs: Changes in Pulse Rate from Baseline

    Measured: From Baseline Up to 12 Weeks

  4. Changes in Respiratory Rate from Baseline

    Vital Signs: Changes in Respiratory Rate from Baseline

    Measured: From Baseline to 12 Weeks

  5. Changes in Blood Pressure from Baseline

    Vital Signs: Changes in Blood Pressure from Baseline

    Measured: From Baseline Up to Week 12

  6. Changes in Temperature from Baseline

    Vital Signs: Changes in Body Temperature from Baseline

    Measured: From Baseline to 12 Weeks

  7. Changes in Hematology Clinical Laboratory Results from Baseline

    Hematology: Changes in results from Baseline

    Measured: From Baseline Up to 12 Weeks

  8. Changes in Chemistry Clinical Laboratory Results from Baseline

    Chemistry: Changes in results from Baseline

    Measured: From Baseline Up to 12 Weeks

  9. Changes in Urinalysis Clinical Laboratory Results from Baseline

    Urinalysis: Changes in results from Baseline

    Measured: From Baseline Up to 12 Weeks

  10. Changes in Coagulation Clinical Laboratory Results from Baseline

    Coagulation: Changes in results from Baseline

    Measured: From Baseline Up to 12 Weeks

Secondary outcomes (13)

  1. Serum Concentrations of KT501

    Blood samples will be collected at specific time points for calculating serum concentrations of KT501

    Measured: Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85.

  2. Incidence of Treatment-induced Anti-Drug Antibodies (ADAs)

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

    Measured: Pre-dose and on Day 1; Day 8, 11, 15, 22, 29, 43, 57 and 85.

  3. To Determine Cmax

    Maximum observed serum KT501 concentration

    Measured: Day 1 - Day 85

  4. To Determine Tmax, Derived from Serum Concentration of each Dose of KT501

    Time to maximum observed concentration

    Measured: Day 1 - Day 85

  5. Area Under the Serum-concentration Time Curve (AUC) from Time Zero to the Last Timepoint with Measurable Analyte Concentration (AUC0-t)

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

    Measured: Day 1 - Day 85

  6. AUC from Time Zero to Infinity (AUCinf)

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

    Measured: Day 1 - Day 85

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

    Terminal elimination half life summarized by dosing regimen

    Measured: Day 1 - Day 85

  8. Total Body Clearance (CL/F)

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

    Measured: Day 1 - Day 85

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

    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.

    Measured: Day 1 - Day 85

  10. Change in Levels of B Cell Count

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

    Measured: Pre-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85.

  11. Duration of B Cell Depletion

    Pharmacodynamics: The duration of B cell depletion measured from Baseline

    Measured: Day 1 - Day 85

  12. Change in Levels of Acute Inflammatory Markers

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

    Measured: Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 15, 22, 29,, 57 and 85.

  13. Changes in Blood Pressure from Baseline

    Vital Signs: Changes in Blood Pressure from Baseline

    Measured: From Baseline to 12 Weeks

Timeline

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

  1. First posted18 Nov 2025
  2. Study start6 Mar 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionAug 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Single Ascending Dose (SAD)
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07234773
Sponsor's protocol ID
KT501-001
Status last verified
Mar 2026
First submitted
13 Nov 2025
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a Phase 1 trial.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KT501 in people with Rheumatoid Arthritis (RA), run by Kali Therapeutics, Inc. at 1 site in Australia.

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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Trial Information (1-858-888-3080, clinical@kalitherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: From Baseline Up to 12 weeks). The study lists 10 primary outcomes in all. 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 NCT07234773.

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 10 Mar 2026.

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