Clinical Trials in Australia / NCT07234773
Recruiting
Phase 1
A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).
NCT07234773 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Rheumatoid Arthritis (RA)
Investigational drug(s) / intervention(s)
KT501
KT501: KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.
Study 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).
Eligibility
Inclusion Criteria:
1. 18 to 75 years old
2. Diagnosis of adult-onset RA for at least 6 months
3. Moderately to severely active RA
4. Inadequate treatment response as defined in the protocol
5. RF + or ACPA+
6. Stable use of traditional DMARDs is permitted
7. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion Criteria:
1. Functional class IV as defined by the ACR Classification of Functional Status in RA
2. Presence of any concomitant autoimmune disease other than RA
3. Active infection, history of serious recurrent or chronic infection
4. History of progressive multifocal leukoencephalopathy
5. Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years.
6. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
7. Receipt of live vaccine within 4 weeks
8. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study
9. Women who are pregnant or breastfeeding
10. Significant or uncontrolled medical disease that would preclude participant participation
Primary outcome measure(s)
- Incidence of Adverse Events — From Baseline Up to 12 weeks
Incidence and severity of Adverse Events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. - Incidence of Cytokine-release Syndrome (CRS) — 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 - Changes in Pulse Rate from Baseline — From Baseline Up to 12 Weeks
Vital signs: Changes in Pulse Rate from Baseline - Changes in Respiratory Rate from Baseline — From Baseline to 12 Weeks
Vital Signs: Changes in Respiratory Rate from Baseline - Changes in Blood Pressure from Baseline — From Baseline Up to Week 12
Vital Signs: Changes in Blood Pressure from Baseline - Changes in Temperature from Baseline — From Baseline to 12 Weeks
Vital Signs: Changes in Body Temperature from Baseline - Changes in Hematology Clinical Laboratory Results from Baseline — From Baseline Up to 12 Weeks
Hematology: Changes in results from Baseline - Changes in Chemistry Clinical Laboratory Results from Baseline — From Baseline Up to 12 Weeks
Chemistry: Changes in results from Baseline - Changes in Urinalysis Clinical Laboratory Results from Baseline — From Baseline Up to 12 Weeks
Urinalysis: Changes in results from Baseline - Changes in Coagulation Clinical Laboratory Results from Baseline — From Baseline Up to 12 Weeks
Coagulation: Changes in results from Baseline
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Kali Study Site | Bayswater | Australia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07234773 on ClinicalTrials.gov ↗ ← All trials in Australia