Rheumatoid Arthritis (RA)Phase 1NCT07564154
A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)
A Phase 1 study testing KT502 in people with Rheumatoid Arthritis (RA), run by Kali Therapeutics, Inc. at 2 sites in 2 countries.
Trial summary
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). 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?
- KT502
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Jul 2026to Jul 2028
- Phase
- Phase 1
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
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- 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
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Kali Therapeutics Trial Site
Bayswater, Victoria
Trial Information, 1.858.888.3080, clinical@kalitherapeutics.com
New Zealand1 site, 1 recruiting
- Recruiting
Kali Therapeutics Trial Site
Auckland, NZ
Trial Information, 1.858.888.3080, clinical@kalitherapeutics.com
About this study
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
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- KT502
- Keywords
- Rheumatoid Arthritis (RA), 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.
KT502Drug
KT502 is a monoclonal antibody that depletes B cells by targeting CD19 and CD3
| Study group | Role | What they receive |
|---|---|---|
| Part A (SAD): Non-Fractionated Single Ascending Doses / Dose Finding | Experimental | Participants will receive a KT502 Subcutaneous Injection at an assigned dose as on Day 1 Receives: Drug: KT502 |
| Part B: Fractionated Dosing / Dose Escalation | Experimental | Participants will receive a KT502 Subcutaneous Injection as a step-up/fractionated dosing on Day 1 and Day 8 Receives: Drug: KT502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
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
Measured: From Baseline Up to 12 weeks
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
Changes in Pulse Rate from Baseline
Vital signs: Changes in Pulse Rate from Baseline
Measured: From Baseline Up to 12 Weeks
Changes in Respiratory Rate from Baseline
Vital Signs: Changes in Respiratory Rate from Baseline
Measured: From Baseline to 12 Weeks
Changes in Blood Pressure from Baseline
Vital Signs: Changes in Blood Pressure from Baseline
Measured: Baseline to 12 Weeks
Changes in Temperature from Baseline
Vital Signs: Changes in Body Temperature from Baseline
Measured: Baseline to 12 Weeks
Changes in Hematology Clinical Laboratory Results from Baseline
Hematology: Changes in results from Baseline
Measured: From Baseline Up to 12 Weeks
Changes in Chemistry Clinical Laboratory Results from Baseline
Chemistry: Changes in results from Baseline
Measured: From Baseline Up to 12 Weeks
Changes in Urinalysis Clinical Laboratory Results from Baseline
Urinalysis: Changes in results from Baseline
Measured: Baseline Up to 12 Weeks
Changes in Coagulation Clinical Laboratory Results from Baseline
Coagulation: Changes in results from Baseline
Measured: From Baseline Up to 12 Weeks
ECG
Change from baseline in 12-lead electrocardiogram (ECG)
Measured: From Baseline to 12 Weeks
Secondary outcomes (12)
Serum Concentrations of KT502
Blood samples will be collected at specific time points for calculating serum concentrations of KT502
Measured: 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)
Immunogenicity: Incidence of participants with treatment induced Anti-Drug Antibodies (ADA)
Measured: 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
Maximum observed serum KT502 concentration
Measured: Day 1 - Day 85
To Determine Tmax, Derived from Serum Concentration of each Dose of KT502
Time to maximum observed concentration
Measured: 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)
Area under the concentration-time curve from 0 to the time of the last quantifiable concentration (AUClast)
Measured: Day 1 - Day 85
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
To Determine Terminal Half-Life (T1/2)
Terminal elimination half-life summarized by dosing regimen
Measured: Day 1 - Day 85
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
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
Change in Levels of B Cell Count
Pharmacodynamics: Change in levels of B cell counts measured at specific timepoints
Measured: Screening; Day 1 - Day 85
Duration of B Cell Depletion
Pharmacodynamics: The duration of B cell depletion measured from Baseline
Measured: Day 1 - Day 85
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; Day 2, 3, 4, 5, 8, 9, 10, 15, 22, 29, 43, 57 and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start13 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Part A: Single Ascending Dose Finding (SAD) Part B: Dose escalation with fractionated dosing
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kali Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564154
- Sponsor's protocol ID
- KT502-001
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2026
- Last updated
- 11 Aug 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.