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 (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07055477 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD25-directed therapy, allogeneic stem cell transplant disqualifies patients from enrollment.
Does this trial require CCR4?
Yes, CCR4 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages