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Immunotherapy trial in Australia, specific for metastatic colorectal cancer, with adoptive cell therapy, subtype CAR T cell therapy (Chimeric Antigen Receptor (CAR) T Cell Therapy.

CNA3103: Leucine-rich repeat-containing G protein-coupled receptor 5 [LGR5]-targeted, autologous Chimeric Antigen Receptor (CAR) -T Cells.
Patients undergo leukapheresis (collection of T cells) and lymphodepletion (chemotherapy), up to 40 days prior to CNA3103 intravenous dosing.
Trial similar to several ongoing at the National Institutes of Health in U.S.
Measurable disease required, prior therapies with Folfox and Folfiri required.
Patients who received third line of treatment (Stivarga, Lonsurf) are NOT allowed. Patients with BRAF mutated cancer are excluded.
First patient has received dose in December 2023.

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Inclusion Criteria

Inclusion Criteria:

Signed written Informed Consent.
Male and female subjects aged greater than or equal to18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Score 0 to 1.
Histologically or cytologically confirmed metastatic colorectal cancer previously treated with 5-FU, oxaliplatin and 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 of at least >12 weeks.
Normal organ and marrow function.
No clinically significant abnormalities in urinalysis results at Screening.
No known clinically significant gastrointestinal disease within 28 days prior to enrolment.
No ongoing requirement for anti-diarrheal therapy.
For female subjects of childbearing potential and male subjects with partners of childbearing potential, agreement (by subject and/or partner) to use a highly effective form of contraception and to continue its use for 6 months after the last dose of IP.
Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to CNA3103 administration.

Exclusion Criteria

Exclusion Criteria:

Inability to comply with study and follow-up procedures.
Women who are pregnant or lactating.
Has BRAF-mutated colorectal cancer.
Has received trifluridine/tipiracil (TAS-102) or regorafenib for metastatic disease.
Treatment with chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiation therapy as cancer therapy within 4 weeks prior to the lymphodepletion start date.
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent in the previous 28 days prior to enrolment.
Have received antibody-based therapies within the previous 28 days or 5 half-lives of the agent, whichever is shorter.
Major surgery, in the previous 4 weeks prior to enrolment.
Clinically detectable third-space fluid collections in the 4 weeks prior to enrolment.
Any uncontrolled medical or psychiatric risk factors which would contraindicate the use or impair the ability of the subject to provide informed consent, receive protocol therapy or may impose excessive risk to the subject.
Known central nervous system (CNS) disease.
Current use of medications that may have the potential of QTc prolongation.
Uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.
Has a known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C, alcoholic or other hepatitis, or cirrhosis.
Inability to be venipunctured and/or tolerate venous access.
Second malignancies within 5 years prior to enrollment, except for those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent.
Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs (NSAIDs), inhaled corticosteroids, or the equivalent of ≤10 mg/day prednisone.
History of inflammatory bowel disease (active or past) or active peptic ulcer disease.
History of connective tissue disorders.
History of chronic leukemias.
History of previous, whole abdomen radiation therapy (or total pelvic radiation therapy) or more than Grade 1 residual toxicity from previous radiation therapy.
High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year
Left ventricular ejection fraction <50%.
Have had a venous thromboembolic event requiring anticoagulation.
Congenital or acquired long QT syndrome.
QTc prolongation.
History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.