A Study of CPTX2309 in Healthy Participants

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: CPTX2309

• Registration Number: NCT06917742
• Lead Sponsor: Capstan Therapeutics

Brief Summary

The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants.

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.

Study Timeline

• Study First Submitted: 2025-03-24
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD Cohorts	CPTX2309	Escalating single doses of CPTX2309 on a specified day
MAD Cohorts	CPTX2309	Escalating multiple doses of CPTX2309 on specified days

Primary Outcome Measures

Name	Time	Method
Number of participants with changes in the safety parameters	8 weeks	To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Number of participants with clinical laboratory assessment abnormalities	8 weeks	To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Number of participants with changes in the vital signs	8 weeks	To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Number of participants with changes in the ECG	8 weeks	To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Number of participants who develop anti-drug antibodies (ADAs) to CPTX2309	8 weeks	To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Number of participants with change from baseline in vaccine antibody titers	8 weeks	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	8 weeks	To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.
Change from baseline in soluble immunoglobulins (Ig)	8 weeks	To evaluate the safety and tolerability of CPTX2309 administered to healthy adult participants.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters	8 weeks	Levels of CAR+ T cells, levels of CPTX2309 components
Pharmacodynamic Parameters	8 weeks	Levels of cytokines and chemokines in nanograms per milliliter of serum by ELISA

Trial Locations

Locations (1)

Nucleus Network Brisbane; 🇦🇺 Herston, Queensland, Australia