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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)

StatusSuspended
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 60 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Stopped Recruitment suspended Sponsor's reason: Placed on hold to conduct a review of events on study. Eligibility criteria expanded, about 20 words · Site details revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Site details revised
  2. Minor 8 versions Re-verified since Jan 10, 2026, no change to tracked fieldsv52-v59
  3. Minor Study Status, Eligibilityv51
  4. Minor Re-verified, no change to tracked fieldsv50
  5. Minor Start date changed from estimate of Oct 6, 2025 to Sep 29, 2025v49
Show 38 earlier versionsHide 38 earlier versions
  1. Minor Start date: Oct 5, 2025 to Oct 6, 2025v48
  2. Minor Start date: Oct 2, 2025 to Oct 5, 2025v47
  3. Minor Start date: Oct 1, 2025 to Oct 2, 2025v46
  4. Minor Start date: Sep 30, 2025 to Oct 1, 2025v45
  5. Minor Start date: Sep 29, 2025 to Sep 30, 2025v44
  6. Minor Start date: Sep 28, 2025 to Sep 29, 2025v43
  7. Minor Start date: Sep 25, 2025 to Sep 28, 2025v42
  8. Minor Start date: Sep 24, 2025 to Sep 25, 2025v41
  9. Minor Start date: Sep 23, 2025 to Sep 24, 2025v40
  10. Minor Start date: Sep 22, 2025 to Sep 23, 2025v39
  11. Minor Start date: Sep 21, 2025 to Sep 22, 2025v38
  12. Minor Start date: Sep 18, 2025 to Sep 21, 2025v37
  13. Minor Start date: Sep 17, 2025 to Sep 18, 2025v36
  14. Minor Start date: Sep 16, 2025 to Sep 17, 2025v35
  15. Minor Start date: Sep 15, 2025 to Sep 16, 2025v34
  16. Minor Start date: Sep 14, 2025 to Sep 15, 2025v33
  17. Minor Start date: Sep 11, 2025 to Sep 14, 2025v32
  18. Minor Start date: Sep 10, 2025 to Sep 11, 2025v31
  19. Minor Start date: Sep 9, 2025 to Sep 10, 2025v30
  20. Minor Start date: Sep 8, 2025 to Sep 9, 2025v29
  21. Minor Start date: Sep 4, 2025 to Sep 8, 2025v28
  22. Minor Start date: Sep 3, 2025 to Sep 4, 2025v27
  23. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2, 2025 to Sep 3, 2025v26 Show 1 more changeShow less
    • Start date: Sep 2, 2025 to Sep 3, 2025
  24. Minor Start date: Sep 1, 2025 to Sep 2, 2025v25
  25. Minor Start date: Aug 31, 2025 to Sep 1, 2025v24
  26. Minor Start date: Aug 28, 2025 to Aug 31, 2025v23
  27. Minor Start date: Aug 27, 2025 to Aug 28, 2025v22
  28. Minor Start date: Aug 26, 2025 to Aug 27, 2025v21
  29. Minor Start date: Aug 25, 2025 to Aug 26, 2025v20
  30. Minor Start date: Aug 22, 2025 to Aug 25, 2025v19
  31. Minor Start date: Aug 21, 2025 to Aug 22, 2025v18
  32. Minor Start date: Aug 20, 2025 to Aug 21, 2025v17
  33. Minor Start date: Aug 19, 2025 to Aug 20, 2025v16
  34. Minor Start date: Aug 17, 2025 to Aug 19, 2025v15
  35. Minor Start date: Aug 14, 2025 to Aug 17, 2025v14
  36. Minor Start date: Aug 13, 2025 to Aug 14, 2025v13
  37. Minor Start date: Aug 11, 2025 to Aug 13, 2025v12
  38. Minor Start date: Aug 10, 2025 to Aug 11, 2025v11
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07055477
Lead Sponsor National Cancer Institute (NCI)
Conditions Relapsed and/or Refractory Mature T Cell Malignancy, Peripheral T-Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Hepatosplenic T-cell Lymphoma, Monomorphic Epithelialtropic Intestinal Lymphoma, Enteropathy Associated T-cell Lymphoma, Cutaneous T-Cell Lymphoma +2 more
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov