A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells)… (NCT07055477) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)
United States60 participantsStarted 2025-09-29
Plain-language summary
Background:
Chemokine receptor 4 (CCR4) is a protein that is found on the surface of certain T-cell lymphoma cells and is common in mature T-cell cancers. White blood cells can be changed with molecules called anti-CCR4 to express a chimeric antigen receptors (CAR), which is a molecule that directs a white blood cell to attack other cells. The CAR in this study attacks the CCR4 protein found on your T-cell lymphoma. This type if therapy is called gene therapy. Gene therapy involves a person s own white blood cells modified to target cancer cells. More research is needed to find out if gene therapy can treat T-cell cancers and do it safely.
Objective:
To test safety of giving people with certain mature T-cell lymphomas their own white blood cells modified with anti-CCR-4 CAR.
Eligibility:
People aged 18 and older with certain mature T-cell lymphomas that have not responded to or have come back after treatment. They must have a T-cell lymphoma that has CCR4 on the surface of the cancer cells.
Design:
Participants will be screened. They will have a medical history and physical exam. Tests of blood, urine, and heart and lung function will be done.
Participants will have tests:
Computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging scans: They will lie on a table that slides into a donut-shaped machine or a tube. Pictures of the inside of the body will be taken. Before the PET scan, they will get an injection of radioactive fluid in a vein in the arm. Before the MRI, they may get a contrast dye injected through a vein (IV) in the arm.
A biopsy of the tumor may be taken. A bone marrow sample may be taken from the hip: The area will be numbed and a large needle inserted through the skin.
Leukapheresis will be done to obtain T-cells that will be genetically modified to express anti-CCR4 CARs on T-cells: Blood is drawn through an IV in one arm, circulated through a machine, and then returned through an IV in the other arm.
Chemotherapy drugs will be given in an IV to prepare the body to accept the modified CAR T cells.
The modified cells will be given in an IV.
Participants will be followed for 15 years: This will require blood tests over the first 1-2 years followed by yearly visits and possibly telehealth updates.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
-CCR4+ is defined as \>= 10% malignant cells positive for CCR4 by immunohistochemistry. It is preferred to have a fresh biopsy to confirm the CCR4 status. In the event a fresh biopsy cannot be safely performed in the opinion of the treating physician, an archival biopsy sample taken at the time of previous progression can be used.
-FEV1 and DLCO \> 60% of predicted (adjustment for Hgb acceptable)
Individuals of child-bearing potential (IOCBP) must have a negative urine or blood HCG pregnancy test at screening.
Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \[IUD\], abstinence, surgical sterilization) or practice abstinence starting at the time of study entry, for the duration of study therapy, and 12 months after the last dose of combined chemotherapy.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase I trial focused primarily on finding a safe dose and understanding the safety profile of CCR4 CAR T cells — not yet proving that they work — what does that mean for what I can realistically hope to gain versus the risks I'd be taking on?
2My specific diagnosis needs to express the CCR4 protein for this trial to be relevant — can you test whether my cancer actually has CCR4 expression, and what happens if it does or doesn't?
3CAR T cell therapies can cause serious side effects like cytokine release syndrome or neurological toxicity — given what's known so far about this particular CCR4 CAR T cell approach, what side effects should I be most prepared for?
4Because this trial uses my own T cells to make the CAR T product, how does that manufacturing process work in practice, and how does my current health or prior treatments affect whether my cells could even be collected and engineered?
5Before considering this trial, are there any standard treatments or other clinical studies I haven't yet tried that you'd recommend I explore first, given that this is an early Phase I study still establishing basic safety?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine safety profile of administering autologous CCR4 CAR T cells