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A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

NCT05759728 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-13

No results posted yet for this study

Summary

This study aims to determine the safety and best response of treatment with CNA3103 (Leucine-rich repeat-containing G protein-coupled receptor 5 \[LGR5\]-targeted, Autologous Chimeric Antigen Receptor (CAR) -T Cells), for participants with Metastatic Colorectal Cancer.

Participants may undergo a pre-screening biopsy procedure to determine expression of LGR5.

Participants will undergo screening procedures, including leukapheresis (collection of T cells) and lymphodepletion (chemotherapy), up to 47 days prior to CNA3103 dosing.

Participants will receive a single Intravenous dose of CNA3103.

Expansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage.

Participants will be followed up, monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression, unacceptable toxicity or intolerable adverse event/s, death or withdrawal of consent.

Conditions

  • Colorectal Cancer Metastatic

Interventions

BIOLOGICAL

CNA3103: 5 x 10^7 cells

CNA3103: 5 x 10\^7 cells - intravenous infusion

BIOLOGICAL

CNA3103: 1.5 x 10^8 cells

CNA3103: 1.5 x 10\^8 cells - intravenous infusion

BIOLOGICAL

CNA3103: 4.5 x 10^8 cells

CNA3103: 4.5 x 10\^8 cells - intravenous infusion

BIOLOGICAL

CNA3103: 1.5 x 10^9 cells

CNA3103: 1.5 x 10\^9 cells - intravenous infusion

BIOLOGICAL

CNA3103: 2.5 x 10^7 cells

CNA3103: 2.5 x 10\^7 cells - intravenous infusion

BIOLOGICAL

CNA3103: 6.75 × 10^8 cells

CNA3103: 6.75 × 10\^8 cells - intravenous infusion

Sponsors & Collaborators

  • Carina Biotech Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759728 on ClinicalTrials.gov