Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus
Conditions
Keywords
Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, CPTX2309
Brief summary
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
Detailed description
A first-in-human Phase 1, open label study to evaluate safety and tolerability of a single ascending dose (SAD) and multiple ascending dose (MAD) of CPTX2309 intravenously administered to healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
Interventions
DRUGCPTX2309
Intravenous Infusion
Sponsors
Capstan Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period. * Participant is willing and able to adhere to the study visit schedule and other protocol requirements. RA Only: * Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA * Presence of rheumatoid factor or ACPA above the ULN * Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)/66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment. SLE Only: * Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria for SLE * Positive ANA\>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).
Exclusion criteria
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted. * Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309. RA Only: \- Participants diagnosed with Felty's syndrome SLE Only: * Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible) * Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with changes in the safety parameters | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. |
| Number of participants with clinical laboratory assessment abnormalities | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. |
| Number of participants with changes in the vital signs | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. |
| Number of participants with changes in the ECG | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. |
| Number of participants who develop anti-drug antibodies (ADAs) and Circulating Immune Complex (CIC) formation | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. |
| Part A and B: Number of participants with change from baseline in vaccine antibody titers | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. |
| Changes in serum cytokine and chemokine levels that are known to be associated with CAR-T cell therapy related toxicity | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. |
| Change from baseline in soluble immunoglobulins (Ig) | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. |
| Part C and D: Change from baseline in vaccination-induced antibody titers | Up to approximately 1 Year | To evaluate the safety and tolerability of CPTX2309 administered to participants with moderate to severe RA and SLE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameters | Up to approximately 1 Year | Levels of CAR+ T cells, levels of CPTX2309 components |
| Pharmacodynamic Parameters | Up to approximately 1 Year | Levels of circulating B cells expressed as the number of CD19 positive B cells in one microliter of blood by flow cytometry |
| Part A and B: Pharmacodynamic Parameters | Up to approximately 1 Year | Percentages of naïve and memory B cells in blood by flow cytometry |
| Part C and D: Number of Participants who develop ADAs | Up to approximately 1 Year | To evaluate the PK profile of CPTX2309 in participants with moderate to severe RA or SLE. |
Countries
Australia
Contacts
CONTACTABBVIE CALL CENTER
Outcome results
None listed