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RECRUITING
NCT05759728
PHASE1/PHASE2

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

Sponsor: Carina Biotech Limited

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a, Multicenter, Open-Label, Dose Escalation and Expansion Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Adult Subjects With Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2023-10-24

Completion Date

2027-12

Last Updated

2026-01-13

Healthy Volunteers

No

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

Locations (1)

Carina Biotech Investigators

Adelaide, South Australia, Australia