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New treatment option for Relapsed and/or Refractory Mature T Cell Malignancy
Official 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)
ClinicalTrials.gov ID: NCT07055477
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed and/or refractory mature t cell malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Pathologically (biopsy) confirmed histologic diagnosis of a relapsed/refractory CCR4+ mature T-cell malignancy from one of the following subtypes...
- Adequate tissue [a formalin fixed tissue block or 15 slides of tumor sample (archival or fresh)] from diagnostic biopsy (archival or fresh) must be...
- Participants must have disease that is relapsed or refractory after prior therapy as follows:
- Participants with ALCL must have failed at least one prior line of Brentuximab-containing therapy.
- Due to the generally indolent nature of the disease, participants with Mycosis Fungoides must have exhausted all standard therapies as determined by...
You likely can't join if
- Participants with any current or prior CNS involvement by malignancy are excluded from this study. All potential participants will be screened with...
- Participants with \>1000 atypical cells/mm\^3 by peripheral blood flow cytometry at screening.
- Participants with a history of serologically or biopsy confirmed autoimmune disorders are excluded from this study. As an exception, participants...
- HTLV I/II positive participants with a history of HTLV-associated myelopathy/tropical spastic paraparesis (TSP)
- Participants who have received prior CD25-directed therapy.
- Current or prior anti-cancer treatment prior to the first dose of study drug as defined below:
See the full eligibility criteria
Who can join
- Pathologically (biopsy) confirmed histologic diagnosis of a relapsed/refractory CCR4+ mature T-cell malignancy from one of the following subtypes: peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)...
- Adequate tissue [a formalin fixed tissue block or 15 slides of tumor sample (archival or fresh)] from diagnostic biopsy (archival or fresh) must be available. NOTE: Tissue will be used for assessment of CCR4 expression...
- Participants must have disease that is relapsed or refractory after prior therapy as follows:
- Participants with ALCL must have failed at least one prior line of Brentuximab-containing therapy.
- Due to the generally indolent nature of the disease, participants with Mycosis Fungoides must have exhausted all standard therapies as determined by the enrolling physician and principal investigator to be eligible for...
- All other participants must have failed at least two lines of prior therapy.
- Participants must have measurable or evaluable disease at the time of enrollment. For participants with systemic T-cell lymphoma, this is defined by any evidence from CT scan or PET-CT-avid disease based on the Lugano...
- Participants must be \>=18 years of age at the time of signing informed consent.
- Adequate performance status (PS) as follows: ECOG PS 0-1.
- Adequate organ function as evidenced by the following laboratory parameters:
- Absolute neutrophil count (ANC) \>= 1,000 /microL
- Platelets \>= 75,000 / microL
- Hemoglobin (Hgb) \>= 9 g/dL (transfusions permitted)
- Creatinine Clearance \>= 60 mL/min/1.73m\^2 per Cockcroft Gault equation; For participants \< 60 per Cockcroft Gault a direct measurement may be used
- Serum total bilirubin \<= 3 X upper limit of normal (ULN)
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \<= 3 X ULN
- Left ventricular ejection fraction \> 50% by echocardiogram performed
- ECG No clinically significant ECG findings (Arrhythmias or evidence of ischemic heart disease with clinical correlate) Note: Participants with well-controlled atrial fibrillation are eligible. --FEV1 and DLCO \> 60% of...
- Nursing participants must be willing to discontinue nursing through 12 weeks after cell infusion.
- Potential participants must agree to stay within 1-hour drive of NIH clinical center from date of initial discharge from hospitalization (no earlier than D+15) through initial D+28 follow-up and be willing and able to...
- Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
What rules you out
- Participants with any current or prior CNS involvement by malignancy are excluded from this study. All potential participants will be screened with brain imaging prior to enrollment on study.
- Participants with \>1000 atypical cells/mm\^3 by peripheral blood flow cytometry at screening.
- Participants with a history of serologically or biopsy confirmed autoimmune disorders are excluded from this study. As an exception, participants with EATL whose celiac disease is well controlled and who will maintain a...
- HTLV I/II positive participants with a history of HTLV-associated myelopathy/tropical spastic paraparesis (TSP)
- Participants who have received prior CD25-directed therapy.
- Current or prior anti-cancer treatment prior to the first dose of study drug as defined below:
- Any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies within 2 weeks before the start of lymphodepleting chemotherapy.
- High doses of systemic corticosteroids (\>20 mg prednisone or equivalent) 5 days before apheresis and/or 5 days before CAR T cell infusion.
- Participants who have not reached D+100 following auto-SCT or who have any unresolved Auto-SCT related complications (e.g. pneumonitis).
- Participants who have undergone prior allogeneic stem cell at any time.
- Participants taking any investigational agents for any disease/ condition.
- Seropositive for human immunodeficiency virus (HIV).
- Active bacterial infections or active viral infections (CMV, syphilis)
- Uncontrolled EBV infection Note: EBV positive test is allowed due to frequent association of active EBV with mature T-cell malignancies, which frequently resolve with improved control of the malignancy. EBV positive...
- Active hepatitis C infection. NOTE: Participants seropositive for hepatitis C virus (HCV) infection must have been treated and cured as defined by undetectable HCV viral load. -Active hepatitis B infection. NOTE...
- Participants with current cardiac atrial or cardiac ventricular lymphoma involvement.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computer tomography (CT) scan...
- History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- Deep vein thrombosis or pulmonary embolism requiring ongoing systemic anticoagulation
- History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
- Participants with second malignancies in addition to their T-cell malignancy are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 3 years or is not in complete...
- Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the participant.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.