A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)

NCT06917742 | Recruiting Phase 1 DMC

• 1 other identifier: CPTX2309-01-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Rheumatoid Arthritis; Systemic Lupus Erythematosus

Keywords

Healthy Volunteers; Rheumatoid Arthritis; Systemic Lupus Erythematosus; CPTX2309

Outcome Measures

Primary Outcomes (9)

• 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.

  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

Secondary Outcomes (5)

• Pharmacokinetic Parameters

  Up to approximately 1 Year

• Pharmacodynamic Parameters

  Up to approximately 1 Year

• Part A and B: Pharmacodynamic Parameters

  Up to approximately 1 Year

• Part A and B: Pharmacodynamic Parameters

  Up to approximately 1 Year

• Part C and D: Number of Participants who develop ADAs

  Up to approximately 1 Year

Study Arms (4)

Part A: SAD Cohorts

EXPERIMENTAL

Escalating single doses of CPTX2309 on a specified day to healthy adult participants.

Drug: CPTX2309

Part B: MAD Cohorts

EXPERIMENTAL

Escalating multiple doses of CPTX2309 on specified days to healthy adult participants.

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.

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.

Drug: CPTX2309

Interventions

CPTX2309 DRUG

Intravenous Infusion

Part A: SAD Cohorts; Part C: SAD Cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Capstan Therapeutics: lead

Study Sites (1)

Nucleus Network Brisbane

Herston, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 8, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)