Cutaneous T-Cell Lymphoma

Researchers are studying the safety, how the body processes, and effectiveness of a drug called CHT101 in adults aged 18 to 70 who have certain types of relapsed or refractory blood cancers, including Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, and Non-Hodgkin Lymphoma. This research is a Phase 1, open-label, single-arm study aiming to find the best dose and observe initial effects in these patients. The treatment involves giving CHT101, a CD70-targeted UCAR-T cell therapy, to participants. The study starts with a dose escalation phase where three dose levels will be tested. After a safety review committee evaluates safety, drug levels in the body, and early responses, a dose expansion phase will begin to further assess the treatment. Participants will be closely monitored for side effects, treatment responses, and how the drug moves and acts in the body over two years. Researchers will measure dose-limiting toxicity and maximum tolerated dose within 28 days of the first infusion. Other outcomes include adverse events, response rates, progression-free survival, overall survival, pharmacokinetics, and pharmacodynamics. Safety and effectiveness will be followed for up to two years after treatment begins.

Researchers are studying the use of unlicensed cryopreserved cord blood units CBUs for transplantation in both children and adults with blood cancers and other related disorders. This observational study involves patients with hematologic malignancies and various inherited and acquired disorders affecting the blood and immune system. The main goal is to monitor how well neutrophil recovery occurs after transplantation using these unlicensed CBUs in multiple institutions. Participants receive unlicensed cryopreserved CBUs as part of their transplant treatment. The study includes patients of any age receiving these CBUs for approved indications. The protocol focuses on the access and distribution of these unlicensed units rather than a specific treatment intervention. The study gathers data from recipients who receive these CBUs, tracking outcomes after transplantation. Participants are monitored for neutrophil recovery at 60 and 100 days after transplant, defined by a neutrophil count of at least 500mm3. Researchers also collect information on infection transmission, infusion reactions, survival rates at one year, and incidence of acute and chronic graft versus host disease. Platelet recovery is also evaluated. Safety and efficacy outcomes are followed over time to better understand the effects of unlicensed CBUs in this patient population.

Researchers are evaluating IM-1021, an antibody-drug conjugate, in a Phase 1 study involving participants with advanced B-cell lymphomas and solid tumors. This first-in-human, open-label study aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1021. The study includes a dose escalation phase to find safe and tolerable doses and an expansion phase to further evaluate these doses in specific cancer types. The study has two parts Part A focuses on escalating doses of IM-1021 given intravenously to determine safety and recommended dosing schedules, including the possibility of alternative dosing. Part B involves expanding participant groups to further test safety and early effectiveness of IM-1021 at doses chosen from Part A. Participants receive the study drug intravenously on an intermittent basis throughout these phases. Participants will undergo multiple assessments including monitoring for treatment-related adverse events, pharmacokinetic blood tests, and evaluations of anti-tumor effects from week 6 until disease progression or study discontinuation. Safety and tolerability will be tracked from the first dose until about 37 days after the last dose. The study duration spans from screening, treatment, and follow-up with data collection continuing up to the study end in 2029.

Researchers are evaluating PTX-100 monotherapy in adult patients with relapsed or refractory Cutaneous T-Cell Lymphoma CTCL to assess its efficacy, safety, pharmacokinetics PK, and pharmacodynamics PD. This open-label, phase 2 randomized study includes patients with confirmed CTCL who have previously received at least two systemic therapies and have measurable disease. The purpose is to better understand how PTX-100 works and determine the optimal dosing for this patient group. PTX-100 will be given by intravenous infusion over 60 minutes on days 1 to 5 of each cycle. In the initial phase Phase 2a, participants will be randomly assigned to receive either 500 mgm2 or 1000 mgm2 doses every 14 days for four cycles, followed by a 21-day cycle for up to 18 months. In the subsequent Phase 2b, 75 participants will receive the recommended optimal dose identified from Phase 2a following the same infusion schedule. Participants will undergo a 28-day screening period before treatment begins. During the study, safety blood tests will be collected on the first day of each cycle, and detailed blood samples will be taken during the first cycle to study how PTX-100 behaves in the body. Patients will also have skin evaluations, safety exams, and quality of life questionnaires at each cycle day 1 visit. The study will continue for up to 18 months or until disease progression, unacceptable side effects, or other reasons for stopping treatment arise.

Researchers are evaluating the safety and effectiveness of tofacitinib 2% cream for treating early-stage Cutaneous T-cell Lymphoma CTCL in stages IA, IB, and IIA. The study focuses on how well the cream works on skin lesions and its safety profile. It also aims to understand the biological changes in tumors before and after treatment. Participants will apply a thin layer of tofacitinib 2% cream twice daily on up to five eligible skin lesions. The trial includes an initial 12-week treatment period with options for extended treatment up to 52 weeks. The study assesses responses using skin severity scores and tracks symptoms like itching and quality of life. During the study, participants will be evaluated at multiple time points with assessments including skin lesion evaluations by mCAILS and mSWAT scores, itch severity scales, and quality of life questionnaires. Safety is monitored throughout the study with adverse event tracking. The total study duration for participants is about one year, with follow-up assessments to monitor ongoing response and safety.

Researchers are studying a gene therapy treatment for adults with certain mature T-cell lymphomas that express the CCR4 protein. This trial focuses on patients whose lymphoma has returned or not responded to previous treatments. The main goal is to evaluate the safety of modifying a persons own white blood cells to attack these cancer cells using a specific receptor called anti-CCR4 CAR. This study is a phase 1, open-label, non-randomized trial conducted by the National Cancer Institute. Participants will first undergo screening, including medical history, physical exams, and several tests such as blood, urine, heart, and lung function tests. Imaging scans like CT, PET, and MRI will be performed to assess the disease. Tumor biopsies and bone marrow samples may also be collected. Participants undergo leukapheresis to collect T-cells, which are then genetically modified to target CCR4 on cancer cells. Before receiving the modified cells, patients will get chemotherapy drugs intravenously to prepare their body. The modified cells are infused through an IV over 10 to 30 minutes. Dose levels will be escalated to find the maximum tolerated dose. After treatment, participants will be followed for up to 15 years with regular blood tests during the first 1 to 2 years and yearly visits or telehealth updates. Researchers will monitor safety, treatment effects, and long-term outcomes, including survival and response rates. Assessments include periodic imaging and lab tests to evaluate the persistence of the modified cells and the participants response to the therapy.

Researchers are evaluating a microdevice designed to release up to 19 different cancer drugs directly into skin lesions of patients with cutaneous T cell lymphoma CTCL or peripheral T cell lymphoma PTCL. This pilot and feasibility study aims to assess the safety of implanting and removing this microdevice and to explore its potential as a tool to identify effective treatments for these lymphomas. The microdevice delivers very small drug doses locally to the tumor tissue, allowing analysis of tumor response without systemic exposure. Participants will have the microdevice implanted into two skin lesions, with multiple devices placed per lesion. The study includes two groups one with patients planning to start standard systemic therapy and another without immediate systemic treatment. Participants will undergo mandatory skin biopsies for additional research. The microdevice is removed after a short period to collect treated tumor tissue for analysis to evaluate local drug effects. During the study, participants will be monitored for any device-related problems or side effects, with safety assessed over two years. Researchers will analyze tumor response to the drugs using tissue samples and advanced laboratory methods including genetic and molecular testing. Standard care treatments will continue as determined by the participants doctors. Participation involves follow-up visits and laboratory testing before and after device placement, lasting up to several years for some outcome measurements.

Researchers are evaluating mogamulizumab-associated rash MAR in patients diagnosed with mycosis fungoides MF or sezary syndrome SS, both types of cutaneous T-cell lymphoma CTCL. The study aims to understand the incidence of MAR and how it relates to the overall response to mogamulizumab treatment. MAR is a common side effect that can resemble the skin symptoms of MF or SS but does not mean the drug is failing it might even indicate the drug is working. Distinguishing MAR from worsening disease could prevent premature stopping of treatment and improve patient care. This is an observational study where patients receiving standard mogamulizumab treatment are followed without changing their therapy. Participants complete questionnaires, have photographs taken of their skin, and give blood samples and skin biopsies when needed to assess for MAR. Medical records are also reviewed to gather comprehensive information about their condition and treatment. Throughout the study, patients will undergo regular assessments including questionnaires, skin photography, blood draws, and skin biopsies if MAR is suspected. Researchers will monitor the occurrence of MAR over up to three years and analyze its association with treatment response. This detailed evaluation will help clarify the characteristics and causes of MAR, improving understanding of patient experiences during mogamulizumab therapy.

Researchers are collecting detailed information in a registry to better understand various types of mature T-cell and natural killer NK-cell lymphomas. This observational study aims to improve knowledge about these rare blood cancers by creating a comprehensive database that includes clinical information and tumor samples from participants. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on multiple specific T-cell lymphoma subtypes as defined by recognized classification guidelines. Participants with confirmed mature T-cell or NK-cell lymphoma may choose to provide optional blood and nail samples for future research and biobanking. The study does not involve experimental treatments but gathers data prospectively from individuals meeting strict diagnostic criteria, including those receiving systemic therapy for certain cutaneous lymphoma types. This approach supports long-term data collection rather than testing new therapies. During the study, participants will have clinical data and tumor specimens collected and recorded. Researchers will track the number of participants contributing to the T-cell Lymphoma Master Repository over a 10-year period. The study involves ongoing follow-up to measure disease status and treatment response, with no direct intervention required. Participation helps build a resource to advance future research and understanding of these lymphomas.

This research aims to evaluate the safety and effectiveness of chidamide when used as a first-line maintenance therapy for patients diagnosed with peripheral T-cell lymphoma PTCL. The study involves a retrospective analysis, collecting past patient data to better understand how chidamide works in this specific treatment setting. Researchers collected detailed information from patients diagnosed with PTCL who received chidamide as maintenance therapy after their initial treatment. The data includes demographics, prior treatments, and results from various tests such as blood work, bone marrow studies, pathology, flow cytometry, next-generation sequencing, and PET-CT scans. The study focuses on assessing chidamides role during this maintenance phase. Participants medical records are reviewed for several outcomes, including progression-free survival over two years, overall survival, complete response rates, and duration of response. Safety data is also analyzed based on these records. This retrospective study does not require active treatment or visits but involves thorough examination of existing clinical data collected at the study center.