Healthy VolunteersPhase 1NCT06917742
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing CPTX2309 in people with Healthy Volunteers and Rheumatoid Arthritis, run by Capstan Therapeutics at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus
- What is being tested?
- CPTX2309
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesAustralia
- Study dates
- 9 Apr 2025to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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).
Who cannot join
- 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/exclusion criteria apply
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 2 recruiting
- Recruiting
Veritus Research
Bayswater, Victoria, 3153
- Completed
Nucleus Network Brisbane
Herston, Queensland, 4006
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
About this study
Official title: A First-in-Human, Phase 1, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers and Subjects With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
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.
Read the 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.
- Being tested
- CPTX2309
- Keywords
- Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, CPTX2309
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPTX2309Drug
Intravenous Infusion
CPTX2309Drug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD Cohorts | Experimental | Escalating single doses of CPTX2309 on a specified day to healthy adult participants. Receives: Drug: CPTX2309 |
| Part B: MAD Cohorts | Experimental | Escalating multiple doses of CPTX2309 on specified days to healthy adult participants. Receives: Drug: CPTX2309 |
| Part C: SAD Cohorts | Experimental | Escalating single doses of CPTX2309 on a specified day to adult participants with moderate to severe RA or SLE. Receives: Drug: CPTX2309 |
| Part D: MAD Cohorts | Experimental | Escalating multiple doses of CPTX2309 on specified days to adult participants with moderate to severe RA or SLE. Receives: Drug: CPTX2309 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 1 Year
Secondary outcomes (5)
Pharmacokinetic Parameters
Levels of CAR+ T cells, levels of CPTX2309 components
Measured: 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
Measured: Up to approximately 1 Year
Part A and B: Pharmacodynamic Parameters
Percentages of naïve and memory B cells in blood by flow cytometry
Measured: Up to approximately 1 Year
Part A and B: Pharmacodynamic Parameters
Levels of cytokines and chemokines in nanograms per milliliter of serum by ELISA
Measured: 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.
Measured: Up to approximately 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start9 Apr 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capstan Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917742
- Sponsor's protocol ID
- CPTX2309-01-01
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers and Subjects With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT06917742
- Acronym / sponsor ID
- CPTX2309-01-01
- Keywords
- Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, CPTX2309
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Capstan TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD Cohorts | Experimental | Drug: CPTX2309Escalating single doses of CPTX2309 on a specified day to healthy adult participants. |
| Part B: MAD Cohorts | Experimental | Drug: CPTX2309Escalating multiple doses of CPTX2309 on specified days to healthy adult participants. |
| Part C: SAD Cohorts | Experimental | Drug: CPTX2309Escalating single doses of CPTX2309 on a specified day to adult participants with moderate to severe RA or SLE. |
| Part D: MAD Cohorts | Experimental | Drug: CPTX2309Escalating multiple doses of CPTX2309 on specified days to adult participants with moderate to severe RA or SLE. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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.
- Participants diagnosed with Felty's syndrome
- 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/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPTX2309Intravenous Infusion | Drug | Part A: SAD Cohorts, Part C: SAD Cohorts |
| CPTX2309Intravenous Infusion | Drug | Part B: MAD Cohorts, Part D: MAD Cohorts |
Primary outcome
Number of participants with changes in the safety parameters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Up to approximately 1 Year
To evaluate the safety and tolerability of CPTX2309 administered to participants with moderate to severe RA and SLE.
5 secondary outcomes
Pharmacokinetic Parameters
Time frame: Up to approximately 1 Year
Pharmacodynamic Parameters
Time frame: Up to approximately 1 Year
Part A and B: Pharmacodynamic Parameters
Time frame: Up to approximately 1 Year
Part A and B: Pharmacodynamic Parameters
Time frame: Up to approximately 1 Year
Part C and D: Number of Participants who develop ADAs
Time frame: Up to approximately 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPTX2309 in people with Healthy Volunteers and Rheumatoid Arthritis, run by Capstan Therapeutics at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with changes in the safety parameters (time frame: Up to approximately 1 Year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.