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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | KT501 Subcutaneous Injection Dose Level 1 |
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| Dose Level 2 | Experimental | KT501 Subcutaneous Injection Dose Level 2 |
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| Dose Level 3 | Experimental | KT501 Subcutaneous Injection Dose Level 3 |
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| Dose Level 4 | Experimental | KT501 Subcutaneous Injection Dose Level 4 |
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| Dose Level 5 | Experimental | KT501 Subcutaneous Injection Dose Level 5 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KT501 | Drug | KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | From Baseline Up to 12 Weeks |
| Changes in Pulse Rate from Baseline | Vital signs: Changes in Pulse Rate from Baseline | From Baseline Up to 12 Weeks |
| Changes in Respiratory Rate from Baseline | Vital Signs: Changes in Respiratory Rate from Baseline | From Baseline to 12 Weeks |
| Changes in Blood Pressure from Baseline | Vital Signs: Changes in Blood Pressure from Baseline | From Baseline Up to Week 12 |
| Changes in Temperature from Baseline | Vital Signs: Changes in Body Temperature from Baseline | From Baseline to 12 Weeks |
| Changes in Hematology Clinical Laboratory Results from Baseline | Hematology: Changes in results from Baseline | From Baseline Up to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of KT501 | Blood samples will be collected at specific time points for calculating serum concentrations of KT501 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Information | Contact | 1-858-888-3080 | clinical@kalitherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kali Study Site | Recruiting | Bayswater | Australia |
This is a Phase 1 trial.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Single Ascending Dose (SAD)
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| Changes in Chemistry Clinical Laboratory Results from Baseline | Chemistry: Changes in results from Baseline | From Baseline Up to 12 Weeks |
| Changes in Urinalysis Clinical Laboratory Results from Baseline | Urinalysis: Changes in results from Baseline | From Baseline Up to 12 Weeks |
| Changes in Coagulation Clinical Laboratory Results from Baseline | Coagulation: Changes in results from Baseline | From Baseline Up to 12 Weeks |
For Immunogenicity: Incidence of participants with treatment induced Anti-Drug Antibodies (ADA) |
| Pre-dose and on Day 1; Day 8, 11, 15, 22, 29, 43, 57 and 85. |
| To Determine Cmax | Maximum observed serum KT501 concentration | Day 1 - Day 85 |
| To Determine Tmax, Derived from Serum Concentration of each Dose of KT501 | Time to maximum observed concentration | 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) | 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 | Day 1 - Day 85 |
| To Determine Terminal Half-Life (T1/2) | Terminal elimination half life summarized by dosing regimen | 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 | 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. | Day 1 - Day 85 |
| Change in Levels of B Cell Count | Pharmacodynamics: Change in levels of B cell counts measured at specific timepoints | Pre-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85. |
| Duration of B Cell Depletion | Pharmacodynamics: The duration of B cell depletion measured from Baseline | 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 | Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 15, 22, 29,, 57 and 85. |
| Changes in Blood Pressure from Baseline | Vital Signs: Changes in Blood Pressure from Baseline | From Baseline to 12 Weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |