Clinical Trials in Australia / NCT07564154
Recruiting
Phase 1
A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)
NCT07564154 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Rheumatoid Arthritis (RA)
Investigational drug(s) / intervention(s)
KT502
KT502: KT502 is a monoclonal antibody that depletes B cells by targeting CD19 and CD3
Study 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). The study will have 2 parts: Part A is a single ascending dose finding (SAD) and Part B is dose escalation by fractionated dosing.
Eligibility
Inclusion:
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:
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, including DLTs, 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 — Baseline to 12 Weeks
Vital Signs: Changes in Blood Pressure from Baseline - Changes in Temperature from Baseline — 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 — 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 - ECG — From Baseline to 12 Weeks
Change from baseline in 12-lead electrocardiogram (ECG)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Kali Therapeutics Trial Site | Bayswater | Victoria | Recruiting |
| Kali Therapeutics Trial Site | Auckland | NZ | Recruiting |
More Kali Therapeutics, Inc. trials in Australia
Other trials for the same condition
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 NCT07564154 on ClinicalTrials.gov ↗ ← All trials in Australia