Actively Recruiting
Phase I Trial of Anti-CCR4 CAR T Cells for CCR4-Expressing Mature T-cell Malignancies Including Peripheral and Cutaneous T-cell Lymphomas
Led by National Cancer Institute (NCI) · Updated on 2026-05-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a gene therapy treatment for adults with certain mature T-cell lymphomas that express the CCR4 protein and have not responded to or have relapsed after previous treatments. This phase I trial aims to test the safety of giving participants their own white blood cells, modified to attack the CCR4 protein on their cancer cells. The study focuses on various T-cell lymphoma subtypes, including peripheral T-cell lymphoma and cutaneous T-cell lymphoma, among others. Participants will first undergo leukapheresis, a procedure to collect their T-cells, which will then be genetically modified to express anti-CCR4 chimeric antigen receptors (CARs). Before receiving the modified cells, participants will have conditioning chemotherapy with cyclophosphamide and fludarabine over three days. The modified CAR T cells will then be infused intravenously. The study includes dose escalation to find the maximum tolerated dose, with groups receiving varying doses, followed by an expansion cohort at the identified dose level. Throughout the trial, participants will undergo extensive monitoring including CT, PET, and MRI scans, biopsies, blood and urine tests, and heart and lung function assessments. Leukapheresis and cell infusions will be carefully timed, and participants will be followed for up to 15 years to assess long-term safety and treatment effects. Visits will include blood tests frequently during the first two years and yearly follow-ups thereafter, with some visits possibly conducted via telehealth.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of relapsed or refractory mature T-cell lymphoma expressing CCR4
- Confirmed CCR4 expression on at least 10% of malignant cells by biopsy
- Measurable or evaluable disease by imaging or clinical criteria
- Adequate organ function and performance status (ECOG 0-1)
- Negative pregnancy test for individuals of child-bearing potential
- Agreement to use effective contraception during and after treatment
- Ability to stay within 1-hour of the study site for initial follow-up
- Willingness and ability to provide informed consent
You will not qualify if you...
- Any current or prior central nervous system involvement by lymphoma
- More than 1000 atypical cells/mm³ in blood at screening
- History of autoimmune disorders (except well-controlled celiac disease or stable thyroiditis)
- Positive HTLV I/II with history of associated neurological disease
- Prior CD25-directed therapy
- Recent anti-cancer treatments within 2 weeks before chemotherapy
- High-dose corticosteroids within 5 days before leukapheresis or cell infusion
- Unresolved complications from prior stem cell transplants
- Use of investigational agents for any condition
- HIV infection
- Active bacterial or viral infections including uncontrolled EBV, hepatitis B or C
- Cardiac involvement by lymphoma or significant heart disease within 12 months
- History of severe lung diseases or active pneumonitis
- Non-malignant CNS disorders or autoimmune CNS diseases
- Current deep vein thrombosis or pulmonary embolism requiring anticoagulation
- Severe allergic reactions to study medications
- Recent second malignancies requiring treatment
- Uncontrolled intercurrent illnesses that increase risk or affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive conditioning chemotherapy with cyclophosphamide and fludarabine followed by infusion of autologous CCR4 CAR T cells.
1 visit for leukapheresis and cell collection; 1 visit for chemotherapy administration; 1 visit for cell infusion
Duration - Up to 15 years
Participants are monitored for safety, treatment effects, and response with periodic imaging and laboratory testing.
Visits at weeks 4 and 12, then every 3 months until Month 12, then at Months 18 and 24, then every 6 months until Month 60, then yearly visits
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
S
Samuel Y Ng, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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