RecruitingPhase 1Phase 2NCT05759728

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

Sponsor

Carina Biotech Limited

Enrollment

45 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a new type of cell therapy called CNA3103 — CAR-T cells genetically engineered from a patient's own immune cells to target a protein (LGR5) found on certain colon cancer cells. The aim is to fight metastatic colorectal cancer that has already been through other treatments. **You may be eligible if...** - You are 18 or older - You have metastatic colorectal cancer confirmed by biopsy - You have had no more than 2 prior rounds of chemotherapy for metastatic disease - Your cancer has spread but your general health is relatively good (ECOG 0–1) **You may NOT be eligible if...** - You have more than 2 prior chemotherapy regimens for metastatic disease - You have active autoimmune disease requiring treatment - You have uncontrolled infections, HIV, or active hepatitis B or C - You have cancer in the brain or spinal cord - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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