Mycosis Fungoides

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 evaluating the safety and effectiveness of Flonoltinib Maleate Tablets in adults with intermediate- or high-risk myelofibrosis, a type of bone marrow disorder. This Phase III clinical trial compares Flonoltinib with the active control drug Ruxolitinib Phosphate. Participants are assigned to one of the two groups based on their risk level using the Dynamic International Prognostic Scoring System DIPSS. The study aims to measure how well these treatments reduce spleen size and improve symptoms over time. Participants take either Flonoltinib 75mg once daily or Ruxolitinib according to prescribed doses twice daily, both taken on an empty stomach. The trial is open-label and conducted at multiple centers, with approximately 105 participants planned for enrollment. Treatment continues until withdrawal criteria are met. The study includes evaluations at various time points up to 24 weeks, focusing on spleen volume reduction and symptom improvement. During the trial, participants undergo regular assessments including physical exams, spleen size measurements using MRI or CT scans, and symptom scoring using the MPN-SAF Total Symptom Score. Blood tests monitor organ function and safety. The primary outcome is the percentage of subjects achieving at least a 35% reduction in spleen volume at week 24. Secondary outcomes include time to spleen response, symptom score changes, and overall survival. Safety and laboratory tests are conducted throughout the study, which lasts several months from enrollment to final assessments.

Researchers are evaluating flonoltinib maleate tablets in adult patients with intermediate to high-risk myelofibrosis MF who are refractory, relapsed, or intolerant to JAK inhibitors. This single-arm, open-label, multicenter phase IIb clinical trial aims to assess the safety and efficacy of this treatment in patients who have limited options after prior JAK inhibitor therapy. Participants will receive flonoltinib maleate tablets orally once daily on an empty stomach. The dose, either 50mg or 75mg, is assigned based on platelet counts measured during the screening period. Treatment continues until participants meet withdrawal criteria. The study includes approximately 64 participants and focuses on those with splenomegaly and specific blood count and organ function criteria. During the study, participants will be monitored regularly for spleen volume reduction, symptom improvement using the MPN-SAF TSS score, and overall survival over 24 weeks. Safety and organ function tests, including blood counts and liver and kidney function, will be performed. Researchers will track treatment effects and side effects throughout the trial duration, with all assessments planned at various time points including weeks 2, 4, 8, 12, and 24.

Researchers are evaluating JAB-8263, a small-molecule inhibitor targeting BET proteins, in adult patients with advanced malignant solid and hematologic tumors in this Phase 12a open-label study. The study aims to find the highest safe dose, assess dose-limiting toxicities, evaluate safety and tolerability, and gather early evidence of antitumor activity in patients whose tumors have progressed despite standard treatments or lack standard options. The study has two parts dose escalation and dose expansion, each enrolling about 30 subjects. Participants receive JAB-8263 orally every two days in 28-day cycles, with dose adjustments to determine the recommended Phase 2 dose. The study monitors how the drug behaves in the body and its preliminary effects on tumors. Participants will undergo evaluations over approximately 18 months, including safety assessments, pharmacokinetic measurements, and tumor response evaluations using standardized criteria. Researchers will record adverse events, response rates, and survival outcomes while monitoring dose-related toxicities. The study does not use randomization or masking, and participants are closely followed to assess treatment effects and safety.

Researchers are studying JV-213, a new type of autologous CAR T-cell therapy targeting CD79b, in adults with relapsed or refractory B-cell lymphomas. The main goal is to find the highest dose of JV-213 that patients can tolerate safely. This Phase 1 trial also aims to evaluate the therapys safety, tolerability, and the best dose to use in future studies. Participants receive JV-213 through an intravenous infusion after their own immune cells are collected via leukapheresis. The study has two parts the first tests increasing doses of JV-213 in small groups to find the maximum tolerated dose, while the second part treats more patients at this recommended dose. Each participants treatment depends on the dose level assigned during the trial. Throughout the study, participants are closely monitored for side effects using standard criteria for adverse events. Researchers also assess tumor response and symptom relief to measure effectiveness. Blood and tumor samples are collected to study how the therapy works in the body and to identify biomarkers linked to treatment response or side effects. The study continues until December 2028, with approximately one year of follow-up after treatment to assess safety and outcomes.

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.