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New treatment option for Colorectal Cancer Metastatic
Official title A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT05759728
What this study is testing
What is CNA3103: 5 x 10^7 cells?
CNA3103: 5 x 10^7 cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written Informed Consent.
- Male and female people 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 no more than 2 prior fluoropyrimidine, oxaliplatin...
- Positive for any level of LGR5 expression in tumor biopsies.
You likely can't join if
- 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 (excluding bridging therapy)...
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent in the previous 28 days prior to...
See the full eligibility criteria
- Signed written Informed Consent.
- Male and female people 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 no more than 2 prior fluoropyrimidine, oxaliplatin, and/or irinotecan-based regimens for metastatic disease. Antibody-drug...
- Positive for any level of LGR5 expression in tumor biopsies.
- Measurable or evaluable disease per RECIST version 1.1. people with lung metastases involving less than or equal to 20% of both lung fields and with good respiratory reserves would be deemed eligible as long as the...
- 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 people of childbearing potential and male people 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...
- Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to CNA3103 administration.
- 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 (excluding bridging 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 pleural effusion requiring drainage 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...
- 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...
- 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.
- Patients with ascites, previous drainage of ascites, peritoneal caking, and/or significant peritoneal deposits at Baseline are excluded from participation in the study
- Patients with reduced liver reserves and/or possibility of hepatobiliary complications, including, but not limited to; portal hypertension, liver resection (segmentectomy, metastasectomy) in the previous 6 months...
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.