NCT05759728

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Carina Biotech Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1/2a, multicenter, open-label study in adult subjects with metastatic colorectal cancer. (CRC). The study will consist of 2 segments: Phase 1 Segment (Dose Escalation): a Bayesian Optimal Interval (BOIN) study design will be used to minimize any risks of exposure to the novel CNA3103 CAR-T cells during dose escalation while determining the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). A minimum of 3 subjects per cohort will be enrolled at each dose level, with appropriate staggering of subjects within and between dose levels. Phase 2a Segment (Dose Expansion): After determination of the MTD/RP2D, additional subjects will be enrolled and treated with CNA3103 at that dose to further assess the safety, PK, pharmacodynamic, and anti-tumor properties of CNA3103. Based upon safety data of these additional subjects, the Sponsor, in consult with the Investigators, may choose to enroll additional subjects at the same or a different dose.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-10-24
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2023-03-08
• Last updated: 2026-01-13

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study