A Study of Intravenous CPTX2309 in Healthy Participants and Participants 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
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.
- Note: Other protocol-defined inclusion/exclusion criteria apply
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06917742
Intervention or treatment
DRUG: CPTX2309
DRUG: CPTX2309
Conditions
- Healthy Volunteers
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
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Research sites nearby
Closest Location:
Nucleus Network Brisbane
Select from list below to view details:
Nucleus Network Brisbane
Herston, Queensland, Australia
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Who is running the clinical trial?
Capstan Therapeutics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Part A: SAD Cohorts
| Drug: CPTX2309 |
EXPERIMENTAL: Part B: MAD Cohorts
| Drug: CPTX2309 |
EXPERIMENTAL: Part C: SAD Cohorts
| Drug: CPTX2309 |
EXPERIMENTAL: Part D: MAD Cohorts
| Drug: CPTX2309 |
What is the study measuring?
Primary Outcome
| 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. | 8 weeks |
| Number of participants with clinical laboratory assessment abnormalities | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. | 8 weeks |
| Number of participants with changes in the vital signs | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. | 8 weeks |
| Number of participants with changes in the ECG | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. | 8 weeks |
| Number of participants who develop anti-drug antibodies (ADAs) to CPTX2309 | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. | 8 weeks |
| Number of participants with change from baseline in vaccine antibody titers | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. | 8 weeks |
| 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. | 8 weeks |
| Change from baseline in soluble immunoglobulins (Ig) | To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants. | 8 weeks |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters | Levels of CAR+ T cells, levels of CPTX2309 components | 8 weeks |
| Pharmacodynamic Parameters | Levels of circulating B cells expressed as the number of CD19 positive B cells in one microliter of blood by flow cytometry | 8 weeks |
| Pharmacodynamic Parameters | Percentages of naïve and memory B cells in blood by flow cytometry | 8 weeks |
| Pharmacodynamic Parameters | Levels of cytokines and chemokines in nanograms per milliliter of serum by ELISA | 8 weeks |
References
Clinical Trials Gov: A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)Other trials to consider
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