Register a trial

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06917742




Registration number
NCT06917742
Ethics application status
Date submitted
24/03/2025
Date registered
8/04/2025

Titles & IDs
Public title
A Study of CPTX2309 in Healthy Participants
Scientific title
A First-in-Human, Phase 1, Single-Center, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers
Secondary ID [1] 0 0
CPTX2309-01-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CPTX2309
Treatment: Drugs - CPTX2309

Experimental: SAD Cohorts - Escalating single doses of CPTX2309 on a specified day

Experimental: MAD Cohorts - Escalating multiple doses of CPTX2309 on specified days


Treatment: Drugs: CPTX2309
Single Escalating Dose of CPTX2309. CPTX2309 is a targeted lipid nanoparticle designed to deliver an anti-CD19 CAR mRNA preferentially to CD8+ T cells.

Treatment: Drugs: CPTX2309
Multiple Escalating Dose of CPTX2309.CPTX2309 is a targeted lipid nanoparticle designed to deliver an anti-CD19 CAR mRNA preferentially to CD8+ T cells.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with changes in the safety parameters
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Number of participants with clinical laboratory assessment abnormalities
Timepoint [2] 0 0
8 weeks
Primary outcome [3] 0 0
Number of participants with changes in the vital signs
Timepoint [3] 0 0
8 weeks
Primary outcome [4] 0 0
Number of participants with changes in the ECG
Timepoint [4] 0 0
8 weeks
Primary outcome [5] 0 0
Number of participants who develop anti-drug antibodies (ADAs) to CPTX2309
Timepoint [5] 0 0
8 weeks
Primary outcome [6] 0 0
Number of participants with change from baseline in vaccine antibody titers
Timepoint [6] 0 0
8 weeks
Primary outcome [7] 0 0
Changes in serum cytokine and chemokine levels that are known to be associated with CAR-T cell therapy related toxicity
Timepoint [7] 0 0
8 weeks
Primary outcome [8] 0 0
Change from baseline in soluble immunoglobulins (Ig)
Timepoint [8] 0 0
8 weeks
Secondary outcome [1] 0 0
Pharmacokinetic Parameters
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Pharmacodynamic Parameters
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Pharmacodynamic Parameters
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Pharmacodynamic Parameters
Timepoint [4] 0 0
8 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network Brisbane - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Capstan Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ramin Farzaneh-Far, MD
Address 0 0
Capstan Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
8583149188
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06917742