Actively Recruiting
A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer
Led by Carina Biotech Limited · Updated on 2026-01-13
45
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Male or female aged 18 years or older.
- ECOG performance status of 0 or 1.
- Metastatic colorectal cancer confirmed by histology or cytology.
- Previously treated with no more than 2 prior chemotherapy regimens for metastatic disease.
- Positive for any level of LGR5 expression in tumor biopsies.
- Measurable or evaluable disease based on RECIST version 1.1 criteria.
- Lung metastases involve 20% or less of both lung fields with good respiratory reserve.
- Life expectancy greater than 12 weeks.
- Normal organ and bone marrow function.
- No significant abnormalities in urinalysis at screening.
- No significant gastrointestinal disease or need for anti-diarrheal therapy within 28 days prior to enrollment.
- Agreement to use highly effective contraception for 6 months after treatment if of childbearing potential.
- Negative pregnancy test within 72 hours before CNA3103 administration for women of childbearing potential.
You will not qualify if you...
- Unable to comply with study and follow-up procedures.
- Pregnant or lactating women.
- BRAF-mutated colorectal cancer.
- Prior treatment with trifluridine/tipiracil (TAS-102) or regorafenib for metastatic disease.
- Cancer therapy (chemotherapy, hormonal, immunotherapy, biologic, or radiation) within 4 weeks before lymphodepletion.
- Use of other investigational agents or participation in another therapeutic clinical trial within 28 days prior to enrollment.
- Received antibody therapies within 28 days or 5 half-lives of the agent.
- Major surgery within 4 weeks prior to enrollment.
- Clinically detectable pleural effusion requiring drainage within 4 weeks prior to enrollment.
- Uncontrolled medical or psychiatric conditions posing excessive risk.
- Known central nervous system disease.
- Use of medications that may prolong QTc interval.
- Uncontrolled infections requiring systemic therapy.
- Known HIV, Hepatitis B or C infection, alcoholic or other hepatitis, or cirrhosis.
- Inability to tolerate venous access.
- Second malignancies within 5 years except certain low-risk cancers.
- Active autoimmune disease not controlled by specified medications.
- History of inflammatory bowel disease or active peptic ulcer disease.
- History of connective tissue disorders.
- History of chronic leukemias.
- Prior whole abdomen or extensive pelvic radiation or significant residual toxicity from radiation.
- High cardiovascular risk including recent coronary stenting or myocardial infarction within past year.
- Left ventricular ejection fraction below 50%.
- History of venous thromboembolism requiring anticoagulation.
- Congenital or acquired long QT syndrome or QTc prolongation.
- History of interstitial lung disease or related lung conditions.
- Presence of ascites, peritoneal caking, or significant peritoneal deposits at baseline.
- Reduced liver function or risk factors for hepatobiliary complications.
- Substance abuse or use of herbal medicines affecting liver health.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Carina Biotech Investigators
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
L
Lina T Jablonskis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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