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 1/2a 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. This phase 1 trial aims to find the highest dose of JV-213 that can be safely given to patients who have not responded to previous treatments. The study also explores how well the treatment works and how it affects the body, including how the immune cells behave and potential biomarkers linked to response and side effects. Participants will receive JV-213 through an intravenous (IV) infusion after their own T cells are collected via leukapheresis. The trial has two parts: a dose escalation phase where small groups receive increasing doses to find the maximum tolerated dose, and a dose expansion phase where more participants receive the recommended dose identified in the first part. Each group includes 3 to 6 patients, and dosing is adjusted based on safety observations. During the study, participants will be monitored closely for side effects using standard criteria and evaluated for tumor response and symptom relief. Researchers will collect blood and tumor samples to study the treatment’s effects and track patient health over about one year. Safety, tumor response rates, duration of response, progression-free survival, and overall survival will be measured throughout the trial.

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 mg/m2 or 1000 mg/m2 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 adults diagnosed with stages IA, IB, or IIA. This phase 2 trial aims to assess how well the cream works on skin lesions and monitor side effects. The study also looks at itch relief, quality of life, and tumor biomarkers before and after treatment. Participants will apply a thin layer of tofacitinib 2% cream twice daily on up to five eligible skin lesions. The treatment phase lasts 12 weeks, with options to extend treatment for up to one year. Researchers will evaluate responses at multiple time points, including weeks 4, 8, 12, and beyond for those continuing treatment. During the study, participants will have regular assessments of their skin lesions using specialized scoring systems, report itch severity, and complete quality of life questionnaires. Safety and adverse events will be monitored throughout the study and up to one year. Tumor samples will be analyzed to understand the biological effects of the cream. Overall participation may last about one year depending on treatment extension.

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.

Researchers are studying a new microdevice designed to release up to 19 different cancer drugs directly into skin lesions caused by cutaneous T cell lymphoma (CTCL) or peripheral T cell lymphoma (PTCL). This pilot and feasibility study aims to evaluate the safety of inserting and removing the microdevice within cancerous lesions and to assess how the device may help identify effective drugs for treating these lymphomas. The FDA has approved all the drugs used in the device, though not specifically for these lymphomas or the microdevice itself. Participants will have up to four microdevices placed percutaneously into two skin lesions, with two devices per lesion. Some patients will also receive standard systemic therapy as determined by their oncologist or dermatologist. Patients in the expansion cohort will receive this standard therapy while their clinical progress is followed. The microdevices release very small doses of drugs directly to the tumor tissue, and after removal, tumor response to the drugs will be analyzed. During the study, participants will undergo skin biopsies and laboratory tests before device placement. Researchers will monitor for any adverse events related to the microdevice over two years and will analyze the quality of tissue retrieved with the device. The study will also evaluate drug responses within the tumor and examine molecular markers using advanced genetic and histological methods over several years. Participation includes follow-ups to assess safety and tumor reactions, with the total follow-up lasting up to five years.

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.