OncoMatch/Clinical Trials/NCT07055477
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)
Is NCT07055477 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Autologous CCR4 CAR T cells and Cyclophosphamide for relapsed and/or refractory mature t cell malignancy.
Treatment: Cyclophosphamide · Fludarabine · Autologous CCR4 CAR T cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCR4 overexpression (>= 10% malignant cells positive for CCR4 by immunohistochemistry)
CCR4+ is defined as >= 10% malignant cells positive for CCR4 by immunohistochemistry
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: Brentuximab-containing therapy — ALCL
Participants with ALCL must have failed at least one prior line of Brentuximab-containing therapy.
Must have received: all standard therapies — Mycosis Fungoides
Participants with Mycosis Fungoides must have exhausted all standard therapies as determined by the enrolling physician and principal investigator to be eligible for this study.
Must have received: any prior therapy — all other participants
All other participants must have failed at least two lines of prior therapy.
Cannot have received: CD25-directed therapy
Participants who have received prior CD25-directed therapy.
Cannot have received: allogeneic stem cell transplant
Participants who have undergone prior allogeneic stem cell at any time.
Lab requirements
Blood counts
ANC >= 1,000 /microL; Platelets >= 75,000 / microL; Hemoglobin >= 9 g/dL (transfusions permitted)
Kidney function
Creatinine Clearance >= 60 mL/min/1.73m^2 per Cockcroft Gault equation; For participants < 60 per Cockcroft Gault a direct measurement may be used
Liver function
Serum total bilirubin <= 3 X ULN; AST and ALT <= 3 X ULN
Cardiac function
Left ventricular ejection fraction > 50% by echocardiogram; ECG: No clinically significant ECG findings (Arrhythmias or evidence of ischemic heart disease with clinical correlate)
Adequate organ function as evidenced by the following laboratory parameters: ... Left ventricular ejection fraction > 50% by echocardiogram performed; ECG No clinically significant ECG findings (Arrhythmias or evidence of ischemic heart disease with clinical correlate)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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