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A phase I/IIa safety, dose finding and feasibility trial of CD30/CEA CART in patients with liver metastases from CEA positive colorectal adenocarcinoma
EU CTIS ID: 2026-526225-18-00
What this study is testing
1) To assess the safety and tolerability of CD30/CEA CART 2) To identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of CD30/CEA CART 3) For feasibility, assess the percent of subjects who receive the planned dose of CD30/CEA CART
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent prior to any clinical trial related activities
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Negative highly-sensitive serum pregnancy test in women of childbearing potential (at screening and before administration of lymphodepleting chemotherapy)
- During the clinical trial and for 12 months after dosing of the IMP women of childbearing potential (WOCBP) and male patients of fathering potential must agree to use highly effective contraceptive methods and to refrain from egg and sperm donation
- Able to adhere to the clinical trial visit schedule and other protocol requirements
You likely can't join if
- Uncontrolled, symptomatic primary tumor of colon or rectum causing obstruction of the bowel, active gastrointestinal bleeding, a history of major gastrointestinal bleeding within 3 months, active severe gastrointestinal ulcers
- Portal vein thrombosis
- Treatment with any prior gene therapy product
- Participation in any clinical trial with administration of an interventional therapy during the previous 28 days or 5 half-lives of the drug, whichever is longer, prior to IMP administration
- Breastfeeding women
- Seropositivity for human immunodeficiency virus (HIV)
See the full eligibility criteria
Who can join
- Signed written informed consent prior to any clinical trial related activities
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Negative highly-sensitive serum pregnancy test in women of childbearing potential (at screening and before administration of lymphodepleting chemotherapy)
- During the clinical trial and for 12 months after dosing of the IMP women of childbearing potential (WOCBP) and male patients of fathering potential must agree to use highly effective contraceptive methods and to refrain from egg and sperm donation
- Able to adhere to the clinical trial visit schedule and other protocol requirements
- Histologically confirmed diagnosis of adenocarcinoma of colon or rectum
- Presence of unresectable liver metastases from colorectal cancer, as assessed and documented by a multidisciplinary tumor board (MDT), due to technical unresectability and/or because surgical resection is not considered appropriate within the overall therapeutic strategy. Note: Patients with additional metastasis in organs other than liver are eligible; for CNS metastasis or leptomeningeal disease see exclusion criterion no. 4
- Radiologically documented disease progression during or after at least two prior lines of guideline-recommended systemic therapy Note: Guideline-recommended systemic therapy includes fluoropyrimidine-based chemotherapy (5-FU or capecitabine) in combination with oxaliplatin and/or irinotecan (doublet or triplet), with or without VEGF- or EGFR targeting monoclonal antibodies, as appropriate. Patients must also have received: - a BRAF inhibitor–based regimen if harboring a BRAF V600E mutation, unless contraindicated - and/or immune checkpoint inhibitor therapy if the tumor is MSI-high or dMMR, unless contraindicated
- No remaining guideline-recommended systemic therapy is available, or the patient is not considered a suitable candidate for such therapy due to lack of expected clinical benefit, prior toxicity, or comorbidities, as determined by the Investigator
- Tumor must be CEA expressing as demonstrated by elevated serum CEA levels (≥ 10 ng/mL)
- Measurable disease per RECIST version 1.1
- Age ≥ 18 years
What rules you out
- Uncontrolled, symptomatic primary tumor of colon or rectum causing obstruction of the bowel, active gastrointestinal bleeding, a history of major gastrointestinal bleeding within 3 months, active severe gastrointestinal ulcers
- Portal vein thrombosis
- Treatment with any prior gene therapy product
- Participation in any clinical trial with administration of an interventional therapy during the previous 28 days or 5 half-lives of the drug, whichever is longer, prior to IMP administration
- Breastfeeding women
- Seropositivity for human immunodeficiency virus (HIV)
- Active hepatitis B virus (HBV) infection; patients with positive serology and HBV viral load below the limit of quantification are allowed
- Active hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed
- Known contraindications to the protocol specified interventions
- Subjects with currently active autoimmune disease requiring immunosuppressive therapy, including, but not limited to immunosuppressive agents such as calcineurininhibitors or corticosteroids (at an equivalent dose of 10 mg prednisone per day, or higher). Physiological replacement, topical, and inhaled steroids are permitted
- Vaccination with live virus vaccines within 6 weeks prior to the start of lymphodepleting therapy
- Rapid progressive disease that in the estimation of the Investigator would compromise ability to complete study therapy
- Subjects with a history of primary immunodeficiency
- Subjects with a currently active second malignancy other than non-melanoma skin cancer or subjects with history of prior malignancy other than colorectal cancer and previously treated with a curative intent therapy less than 1 year ago
- Known or suspected hypersensitivity or intolerance to IMP and/or any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy, pre-medication for infusion, rescue medication/salvage therapies for treatment of toxicities.
- Receipt of allogenic stem cell transplantation in the 5 years prior to enrollment into the trial
- Patients with acute or chronic graft versus host disease
- Patients with inflammatory conditions like chronic inflammatory bowel disease or acute/chronic pancreatitis
- Confirmed or suspected central nervous system (CNS) metastases or leptomeningeal disease (meningeosis carcinomatosa). Patients who had had radiotherapy or another appropriate therapy for the brain or spinal metastases AND have no neurological symptoms AND have at least stable disease on computer tomography (CT) or magnetic resonance imaging (MRI) scan for at least 4 weeks may be eligible.
- Local ablation therapies, such as invasive local ablation (radiofrequence ablation [RFA], microwave), precision radiotherapy (stereotactic body radiation therapy [SBRT], brachytherapy or embolization techniques [any particles, beads, selective internal radiation therapy; SIRT]) within 28 days prior to IMP administration
- Concurrent or recent prior therapies: a. Antiproliferative chemotherapies, monoclonal antibodies, checkpoint inhibitors, immunosuppressants other than corticosteroids within 14 days prior to leukapheresis b. Systemic corticosteroids with the exception of physiologic replacement dosing within 7 days prior to leukapheresis c. Short acting molecularly targeted agents (tyrosine kinase inhibitors) within 72 hours prior to leukapheresis
- Any clinically significant, advanced or unstable disease, condition or inadequate main organ function that may put the subjects at special risk.
- Subjects with ongoing (incl. controlled) infections or infestations that may put the subject at special risk.
- Subject has any of the following laboratory abnormalities or conditions: a. White blood cell (WBC) count < 3 × 109/L b. Absolute neutrophil count (ANC) < 1.5 × 109/L (patient may not use G-CSF to achieve ANC ≥ 1.5 × 109/L) c. Absolute lymphocyte count < 300 /μL d. Platelet count < 100 × 109/L e. Hemoglobin (Hgb) < 9 g/dL f. Creatinine clearance < 30 mL/min by Cockroft-Gault formula g. Total bilirubin > 2 times the upper normal serum level or Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) > 5 times the upper normal serum level unless due to CRC metastases in the estimation of the Investigator h. International normalized ratio (INR) > 1.5 and a PTT > 1.2 times the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters i. Congestive heart failure NYHA ≥ 3 j. Severe restrictive or obstructive lung disease
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.