A Study of CPTX2309 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-09

Study Completion Date

2026-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAD Cohorts

Escalating single doses of CPTX2309 on a specified day

Group Type EXPERIMENTAL

CPTX2309

Intervention Type DRUG

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

MAD Cohorts

Escalating multiple doses of CPTX2309 on specified days

Group Type EXPERIMENTAL

CPTX2309

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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 Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes