Actively Recruiting
A Phase 1/2a, Open-Label Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) in Adults With Metastatic Colorectal Cancer
Led by Carina Biotech Limited · Updated on 2026-01-13
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and best response of CNA3103, a novel treatment using LGR5-targeted, autologous CAR-T cells, in adults with metastatic colorectal cancer. This Phase 1/2a open-label study involves participants who have previously received up to two prior chemotherapy regimens for metastatic disease. The study aims to find the maximum tolerated dose and recommended dose for further research while assessing the treatment's safety and anti-tumor effects. Participants will undergo initial screening, including a biopsy to confirm LGR5 expression and leukapheresis to collect T cells. Before receiving CNA3103, they will have lymphodepletion chemotherapy. They will then receive a single intravenous dose of CNA3103. The study has two parts: a dose escalation phase to find the best dose and a dose expansion phase to further evaluate safety and effects at that dose. After treatment, participants will be monitored for up to two years. During the study, participants will attend regular visits for safety checks, research tests, and monitoring of disease progression or side effects. Assessments include measuring how well the cancer responds, tracking survival, and testing the presence of the viral construct used to deliver the therapy. Follow-up continues until disease progression, unacceptable side effects, death, or withdrawal, ensuring detailed observation of the treatment's impact over time.
CONDITIONS
Brief 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 and female subjects aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 1.
- Histologically or cytologically confirmed metastatic colorectal cancer treated with no more than 2 prior fluoropyrimidine, oxaliplatin, and/or irinotecan-based regimens for metastatic disease.
- Positive for any level of LGR5 expression in tumor biopsies.
- Measurable or evaluable disease per RECIST version 1.1.
- Life expectancy greater than 12 weeks.
- Normal organ and marrow function.
- No clinically significant abnormalities in urinalysis at screening.
- No known significant gastrointestinal disease within 28 days prior to enrollment.
- No ongoing requirement for anti-diarrheal therapy.
- Agreement to use highly effective contraception for 6 months after last dose for females of childbearing potential and male partners.
- Negative serum pregnancy test within 72 hours prior to CNA3103 administration for women of childbearing potential.
You will not qualify if you...
- Inability to comply with study and follow-up procedures.
- Women who are pregnant or lactating.
- Presence of BRAF-mutated colorectal cancer.
- Prior treatment with trifluridine/tipiracil (TAS-102) or regorafenib for metastatic disease.
- Cancer therapy including chemotherapy, hormonal, immunotherapy, biologic, or radiation within 4 weeks prior to lymphodepletion.
- Participation in another clinical trial with therapeutic intent within 28 days prior to enrollment.
- Recent antibody-based therapies within 28 days or 5 half-lives.
- 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 that increase risk or impair consent.
- Known central nervous system disease.
- Use of medications that may prolong QTc interval.
- Uncontrolled infections requiring systemic therapy.
- Known HIV, Hepatitis B or C infections, alcoholic or other hepatitis, or cirrhosis.
- Inability to tolerate venous access.
- Second malignancies within 5 years except low-risk cancers.
- Active autoimmune diseases uncontrolled by standard therapies.
- History of inflammatory bowel disease or active peptic ulcer disease.
- History of connective tissue disorders.
- History of chronic leukemias.
- Previous whole abdomen or total pelvic radiation therapy or residual toxicity from prior radiation.
- High cardiovascular risk including recent coronary stenting or myocardial infarction.
- Left ventricular ejection fraction below 50%.
- Recent venous thromboembolic event requiring anticoagulation.
- Congenital or acquired long QT syndrome or QTc prolongation.
- History of interstitial lung disease or related pulmonary conditions.
- Presence of ascites, peritoneal caking, or significant peritoneal deposits at baseline.
- Reduced liver reserves or hepatobiliary complications.
- Substance abuse or use of herbal medicines that may affect liver function.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive a single intravenous infusion of CNA3103 CAR-T cells at Day 0 to treat metastatic colorectal cancer.
1 treatment visit and several follow-up visits within 28 days
Duration - Up to 24 months
Participants are monitored for safety, pharmacokinetics, treatment response, and overall survival after treatment.
Regular visits for up to 24 months
Trial Site Locations
Total: 1 location
1
Carina Biotech Investigators
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
L
Lina T Jablonskis, PhD
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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