Safety, Dose‑Finding and Feasibility Study of CD30/CEA CART in Patients with Liver Metastases from CEA‑Positive Colorectal Cancer

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What is this study about?

The study focuses on patients with Colorectal Adenocarcinoma that has spread to the liver and shows a CEA positive tumor marker. The investigational therapy is called CD30/CEA CART, which uses the patient’s own autologous T cells that are genetically altered in a laboratory so they can recognize and attack cancer cells expressing the CD30 and CEA proteins. The modified cells are given through an IV infusion, a process similar to a blood transfusion.

The main aim is to evaluate how safe the treatment is, to determine the appropriate dose, and to see whether the treatment can be given as planned. Researchers will watch for dose‑limiting toxicities (DLT), which are side effects that prevent increasing the dose, and will identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). All side effects will be graded using the standard CTCAE system, which classifies how severe each reaction is.

Participants will first have blood drawn so their T cells can be collected and modified. After a short waiting period, the modified cells are infused, and patients will be monitored regularly with clinic visits, blood tests, and imaging scans to check for side effects and any changes in tumor size. Tumor response will be assessed using the widely accepted RECIST criteria, which define an objective response rate as the proportion of patients whose tumors shrink by a predetermined amount.

1 enrollment and baseline assessments

after signing the informed consent form, you will undergo initial medical evaluations that include physical examination, blood tests, and imaging studies to confirm eligibility.

these baseline assessments establish a reference point for later comparison of safety and treatment effects.

2 collection of autologous t cells (leukapheresis)

a procedure called leukapheresis will be performed to collect your own t cells from the bloodstream.

the collected cells are sent to a specialized laboratory where they will be genetically modified to create cd30/cea cart cells.

3 manufacturing of cd30/cea cart cells

in the laboratory, your t cells are engineered to express a chimeric antigen receptor that targets cd30 and cea proteins on cancer cells.

this manufacturing process usually takes several weeks; during this time you will continue routine medical care and may have periodic safety check‑ins.

4 pre‑infusion safety checks

before receiving the study medication, you will have a repeat set of vital‑sign measurements, blood tests, and possibly imaging to ensure you are ready for infusion.

any new symptoms or changes in health will be reviewed by the study team.

5 administration of cd30/cea cart

the engineered cells are given as a intravenous infusion of a suspension for infusion.

the exact dose is determined by the study protocol and may be adjusted as part of the dose‑finding schedule; typically a single infusion is administered in the hospital setting.

the infusion may last from several minutes to a few hours, depending on the dose and your tolerance.

6 immediate post‑infusion monitoring

after the infusion you will remain under observation for at least 24 hours to monitor for adverse events such as fever, low blood pressure, or other reactions.

blood samples will be taken regularly during this period to assess early safety signals and to measure the level of cd30/cea cart cells in your blood.

7 scheduled follow‑up visits for safety and efficacy

you will return for follow‑up visits at defined intervals (for example, week 1, week 2, week 4, and then monthly) during the first 3 months.

each visit includes physical examination, laboratory tests, and imaging studies to evaluate tumor response and to detect any late‑onset side effects.

the study also tracks the proportion of patients who receive the planned dose, the occurrence of dose‑limiting toxicities during the first 28 days, and overall treatment tolerability.

8 long‑term follow‑up

after the initial 3‑month period, you will continue periodic assessments for up to two years to monitor disease status, overall survival, and any long‑term safety concerns.

these visits may be spaced further apart (for example, every three to six months) and will include blood work, imaging, and questionnaires about your health.

Who Can Join the Study?

Signed written informed consent before any study activities – you must read and sign a document that explains the trial and agree to take part.
Life expectancy of at least 3 months – doctors need to be sure you are expected to live for at least three more months.
ECOG performance status 0‑1 – a simple scale of daily activity where 0 means fully active and 1 means able to do light work but not fully active.
Negative pregnancy test for women who could become pregnant – a blood test must show you are not pregnant before starting treatment.
Use of effective birth control – during the study and for 12 months after treatment, women who could become pregnant and men who could father a child must use reliable contraception and agree not to donate eggs or sperm.
Ability to follow the visit schedule – you must be able to come to all required appointments and follow study instructions.
Confirmed diagnosis of colon or rectum adenocarcinoma – a tissue test (biopsy) must show you have this type of cancer.
Unresectable liver metastases – cancer that has spread to the liver and cannot be removed by surgery, as decided by a team of cancer doctors (tumor board). Having cancer in other organs is allowed.
Progression after at least two standard treatments – scans must show the disease is getting worse after you have tried at least two recommended chemotherapy regimens, and if your tumor has a BRAF mutation you must have tried a BRAF‑inhibitor drug, or if it is MSI‑high/dMMR you must have tried an immune‑checkpoint inhibitor, unless these were not suitable for you.
No further standard therapy available or suitable – your doctor must determine that no other recommended treatments are left, or that they would not be helpful because of side effects or other health problems.
Elevated CEA level (≥ 10 ng/mL) – a blood test must show a high level of carcinoembryonic antigen, a marker that indicates the tumor is producing this protein.
Measurable disease – imaging tests (like CT or MRI) must show tumors that can be measured according to standard criteria (RECIST 1.1).
Age 18 years or older – you must be an adult.

Who Cannot Join the Study?

Having an active colon or rectal tumor that is causing a blockage, bleeding, or serious ulcers (bleeding in the stomach or intestines).
Portal vein thrombosis – a blood clot in the main vein that carries blood from the intestines to the liver.
Having received any gene therapy product before.
Being in another clinical trial that gave a treatment within the last 28 days (or longer if the drug stays in the body for a long time).
Being a breastfeeding woman.
Testing positive for HIV (the virus that causes AIDS).
Having an active hepatitis B infection (a virus that affects the liver).
Having an active hepatitis C infection (another virus that affects the liver).
Having any known reason that makes the study treatments unsafe for you.
Having an active autoimmune disease that requires strong immune‑suppressing medicines such as high‑dose steroids or other drugs (autoimmune disease = the immune system attacks the body).
Having received a live‑virus vaccine (e.g., measles, mumps, rubella) within the past 6 weeks (live virus vaccine = a vaccine that contains a weakened virus).
If your cancer is growing very quickly and the doctor thinks you couldn’t finish the study treatment.
Having a history of primary immunodeficiency (a condition you are born with that weakens the immune system).
Having another active cancer (except a simple skin cancer) or having had a different cancer treated with curative intent less than one year ago.
Being known to be allergic or intolerant to the study drug or any other medication used during the trial.
Having received an allogenic stem cell transplant (receiving blood‑forming cells from a donor) within the past 5 years.
Having acute or chronic graft‑versus‑host disease (a condition where donor immune cells attack the recipient’s body after a transplant).
Having inflammatory conditions such as chronic inflammatory bowel disease (long‑term inflammation of the intestine) or acute/chronic pancreatitis (inflammation of the pancreas).
Having cancer that has spread to the brain or spinal cord (CNS metastases) or to the membranes covering them (leptomeningeal disease).
Having had any local tumor‑destroying procedures (e.g., radiofrequency ablation, microwave ablation, special radiation, brachytherapy, embolization, or SIRT) within the last 28 days.
Having received certain chemotherapy, immune‑targeting drugs, strong steroids, or specific targeted medicines shortly before the blood collection for the study (within 14 days, 7 days, or 72 hours respectively). (Leukapheresis = collecting your white blood cells for the therapy.)
Having any serious, advanced, or unstable health problem or organ that is not working well enough, which could put you at special risk.
Having an ongoing infection or infestation (including controlled infections) that could increase your risk.
Having any of the following lab test results:
- White blood cell count less than 3 × 10⁹/L.
- Absolute neutrophil count less than 1.5 × 10⁹/L (cannot use G‑CSF to raise it).
- Absolute lymphocyte count less than 300 /µL.
- Platelet count less than 100 × 10⁹/L.
- Hemoglobin less than 9 g/dL.
- Creatinine clearance less than 30 mL/min (a measure of kidney function).
- Total bilirubin more than twice the normal level, or ALT/AST more than five times normal (unless due to cancer spread).
- INR greater than 1.5 and PTT greater than 1.2 times normal (blood clotting tests), unless you are on stable blood thinners for a cancer‑related clot.
- Congestive heart failure NYHA class 3 or higher (moderate to severe heart failure symptoms).
- Severe restrictive or obstructive lung disease.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Usaaatgtzsvvxckkwxwut Rxscjojjzk Ayn	Regensburg	Germany
Uekucofynhowfkpufjllm Eafqybuq Alk	Erlangen	Germany
Ubxdgcakwqirthbkogijw Whbqgaqky Aww	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.07.2026

Trial locations

CD30/CEA CART is a personalized cell therapy made from a patient’s own immune cells. Doctors take the patient’s T‑cells, a type of white blood cell, and modify them in the lab so they carry a special receptor that can recognize two targets, CD30 and CEA, which are often found on colorectal cancer cells that have spread to the liver. After the modification, the cells are grown into a suspension that can be given through an IV infusion. In the trial, this therapy is being tested to see if it is safe, how well patients can tolerate it, and what dose might be best for future studies. The goal is to find out if the modified cells can help the immune system attack the liver metastases without causing serious side effects.

Investigated Diseases:

Colorectal adenocarcinoma

Colorectal Adenocarcinoma – Colorectal adenocarcinoma is a type of cancer that starts in the lining of the colon or rectum. It begins as a small abnormal growth that can enlarge over time. As it grows, it may invade the wall of the colon and spread to nearby tissues. The tumor can also travel through the blood or lymph system to other parts of the body. Symptoms often appear as the tumor becomes larger or spreads.

Trial ID:

2026-526225-18-00

Protocol code:

CD30/CEA CART_001

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Safety, Dose‑Finding and Feasibility Study of CD30/CEA CART in Patients with Liver Metastases from CEA‑Positive Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?