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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAD Cohorts | Experimental | Escalating single doses of CPTX2309 on a specified day to healthy adult participants. |
|
| Part B: MAD Cohorts | Experimental | Escalating multiple doses of CPTX2309 on specified days to healthy adult participants. |
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| Part C: SAD Cohorts | Experimental | Escalating single doses of CPTX2309 on a specified day to adult participants with moderate to severe RA or SLE. |
|
| Part D: MAD Cohorts | Experimental | Escalating multiple doses of CPTX2309 on specified days to adult participants with moderate to severe RA or SLE. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPTX2309 | Drug | Intravenous Infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with changes in the safety parameters | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Number of participants with clinical laboratory assessment abnormalities | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Number of participants with changes in the vital signs | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Number of participants with changes in the ECG | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Number of participants who develop anti-drug antibodies (ADAs) and Circulating Immune Complex (CIC) formation | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Part A and B: Number of participants with change from baseline in vaccine antibody titers | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters | Levels of CAR+ T cells, levels of CPTX2309 components | Up to approximately 1 Year |
| Pharmacodynamic Parameters | Levels of circulating B cells expressed as the number of CD19 positive B cells in one microliter of blood by flow cytometry |
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Inclusion Criteria:
RA Only:
SLE Only:
Exclusion Criteria:
RA Only:
- Participants diagnosed with Felty's syndrome
SLE Only:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Brisbane | Recruiting | Herston | Queensland | 4006 | Australia |
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| CPTX2309 |
| Drug |
Intravenous Infusion |
|
| Up to approximately 1 Year |
| Changes in serum cytokine and chemokine levels that are known to be associated with CAR-T cell therapy related toxicity | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Change from baseline in soluble immunoglobulins (Ig) | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants and participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Part C and D: Change from baseline in vaccination-induced antibody titers | To evaluate the safety and tolerability of CPTX2309 administered to participants with moderate to severe RA and SLE. | Up to approximately 1 Year |
| Up to approximately 1 Year |
| Part A and B: Pharmacodynamic Parameters | Percentages of naïve and memory B cells in blood by flow cytometry | Up to approximately 1 Year |
| Part A and B: Pharmacodynamic Parameters | Levels of cytokines and chemokines in nanograms per milliliter of serum by ELISA | Up to approximately 1 Year |
| Part C and D: Number of Participants who develop ADAs | To evaluate the PK profile of CPTX2309 in participants with moderate to severe RA or SLE. | Up to approximately 1 Year |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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