A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KT501.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
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.
Interventions
- Drug KT501
KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.
Primary outcome measures
- Incidence of Adverse Events [Time frame: From Baseline Up to 12 weeks]
- Incidence of Cytokine-release Syndrome (CRS) [Time frame: From Baseline Up to 12 Weeks]
- Changes in Pulse Rate from Baseline [Time frame: From Baseline Up to 12 Weeks]
- Changes in Respiratory Rate from Baseline [Time frame: From Baseline to 12 Weeks]
- Changes in Blood Pressure from Baseline [Time frame: From Baseline Up to Week 12]
- Changes in Temperature from Baseline [Time frame: From Baseline to 12 Weeks]
- Changes in Hematology Clinical Laboratory Results from Baseline [Time frame: From Baseline Up to 12 Weeks]
- Changes in Chemistry Clinical Laboratory Results from Baseline [Time frame: From Baseline Up to 12 Weeks]
- Changes in Urinalysis Clinical Laboratory Results from Baseline [Time frame: From Baseline Up to 12 Weeks]
- Changes in Coagulation Clinical Laboratory Results from Baseline [Time frame: From Baseline Up to 12 Weeks]
Secondary outcome measures (12)
- Serum Concentrations of KT501 [Time frame: Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85.]
- Incidence of Treatment-induced Anti-Drug Antibodies (ADAs) [Time frame: Pre-dose and on Day 1; Day 8, 11, 15, 22, 29, 43, 57 and 85.]
- To Determine Cmax [Time frame: Day 1 - Day 85]
- To Determine Tmax, Derived from Serum Concentration of each Dose of KT501 [Time frame: 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) [Time frame: Day 1 - Day 85]
- AUC from Time Zero to Infinity (AUCinf) [Time frame: Day 1 - Day 85]
- To Determine Terminal Half-Life (T1/2) [Time frame: Day 1 - Day 85]
- Total Body Clearance (CL/F) [Time frame: Day 1 - Day 85]
- Volume of Distribution During the Terminal Phase (Vz/F) [Time frame: Day 1 - Day 85]
- Change in Levels of B Cell Count [Time frame: Pre-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85.]
- Duration of B Cell Depletion [Time frame: Day 1 - Day 85]
- Change in Levels of Acute Inflammatory Markers [Time frame: Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 15, 22, 29,, 57 and 85.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Kali Study Site — Bayswater
Identifiers
NCT: NCT07234773 · KT501-001