Burkitt Lymphoma

Researchers are evaluating a new type of CAR T cell therapy called 4SCAR19U T cells for treating patients with CD19-positive B cell malignancies. This phase I trial aims to assess the feasibility, safety, and effectiveness of this universal CAR T cell product in patients who have relapsed or refractory hematological cancers. The study also investigates how these cells function and persist in the body. The trial is sponsored by Shenzhen Geno-Immune Medical Institute and conducted at multiple centers. The 4SCAR19U T cells are genetically engineered and produced in large amounts, allowing them to be stored and used off-the-shelf without needing to be custom-made for each patient. This makes treatment quicker and potentially more accessible, especially for patients with rapidly progressing disease or weakened immune systems after chemotherapy or radiotherapy. Participants will receive infusions of these universal CD19-specific CAR T cells as the investigational therapy. Participants will be monitored for safety over 24 weeks following the infusion to observe any side effects or adverse events. The study will also evaluate the anti-tumor activity of the 4SCAR19U cells for up to one year. Assessments include clinical evaluations, laboratory tests, and tracking of the cells persistence in the body. The trial plans to enroll patients aged from 6 months to 75 years, with specific health and response criteria, and participation could last until the studys end date in 2030.

Researchers are evaluating BGB-16673, an oral drug, in adults with various types of B-cell malignancies such as marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrm macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. This study includes Phase 1 dose finding and safety expansion, followed by Phase 2 expansion cohorts to determine recommended doses and further assess safety and efficacy. The study is divided into several parts, starting with Phase 1 dose escalation to find safe dosage levels, including monotherapy dose escalation and safety expansion in selected doses. Phase 2 involves expansion cohorts where participants receive the recommended doses identified in Phase 1 for further safety and efficacy evaluation. Some cohorts include participants who have not received prior BTK inhibitors, and Japanese participants are also enrolled to assess safety. Treatments are orally administered. Participants will undergo regular assessments including monitoring for adverse events, disease response, and drug concentration levels in the blood at various time points. Researchers will measure outcomes such as overall response rate and progression-free survival over approximately three years. Safety and tolerability will be closely tracked, and quality of life questionnaires will be completed at scheduled intervals. Participation may last several years, including follow-up periods to monitor long-term effects.

Researchers are investigating new medicines for children and young people up to 25 years old with relapsed or refractory B-cell non-Hodgkin Lymphoma B-NHL, a type of cancer affecting lymph nodes and organs like the liver or spleen. This international adaptive trial aims to find safer and more effective treatments, focusing on three groups receiving different novel therapies. The study uses a design that allows adding or removing treatments based on their effectiveness and safety in this rare cancer. Participants will receive one of three treatments odronextamab given by intravenous infusion weekly and then less frequently over up to two years loncastuximab tesirine combined with modified R-ICE chemotherapy for up to three cycles or CAR T-cell therapy with details to be confirmed. These treatments are tested in parallel groups, and if a medicine appears ineffective, it may be stopped and replaced by another. The trial allows children to switch groups if their cancer does not respond. During the study, researchers will monitor participants through regular assessments including imaging and laboratory tests to evaluate cancer response and side effects. They will check treatment responses at specific times during treatment cycles and follow patients for at least two years after treatment to monitor long-term outcomes and safety. This includes tracking survival times, adverse events, and overall treatment effectiveness to provide important information about these new therapies.

Researchers are investigating a new combination of three drugsazacitidine, venetoclax, and tagraxofuspto treat patients with Acute Myeloid Leukemia AML who have leftover leukemia cells that cannot be seen with the naked eye. This Phase 12 clinical trial aims to assess the safety and how well this drug combination controls residual AML and prevents the disease from coming back. The study builds on FDA approvals of venetoclax and azacitidine together for AML and tagraxofusp alone for another leukemia type, but this combination is not yet FDA-approved for AML treatment. The study involves two groups of participants. In Phase 1, up to 12 people receive escalating doses of tagraxofusp combined with fixed doses of azacitidine and venetoclax to find the safest and best dose. Treatment cycles last 28 days, with azacitidine given daily for seven days, tagraxofusp infused on days 4 to 6, and venetoclax taken on days 1 and 14. In Phase 2, 19 participants receive the recommended dose of tagraxofusp plus azacitidine and venetoclax with the same schedule. Bone marrow biopsies and aspirations occur regularly during treatment to monitor response. After treatment, participants are followed for up to two years. Participants will have regular visits including blood tests, imaging scans like CT, MRI, or PET, heart function tests, and bone marrow examinations. Researchers will monitor for side effects, measure disease remission, and check for minimal residual disease to evaluate treatment impact. The study expects to last about four years with around 31 participants. Outcomes such as remission duration, survival, relapse rates, and safety events will be assessed during treatment and follow-up.

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 whether telehealth music therapy can be a practical treatment for cognitive difficulties in adults who have survived blood cancers such as lymphoma, leukemia, or myeloma. The study also examines if music therapy and music education can help improve cognitive function as well as symptoms like anxiety, depression, and fatigue in this population. This pilot trial is exploring these effects in hematologic cancer survivors who experience cancer-related cognitive dysfunction. Participants will be assigned to one of three groups the experimental music therapy MT group, the therapist-attention music education TAME control group, or a wait-list control WLC group receiving usual care. Those in the MT and TAME groups will receive 12 weekly 60-minute sessions, with homework assignments between sessions to reinforce skills and concepts. The WLC group completes assessments during a 24-week wait period and can later choose to receive either the MT or TAME intervention. During the study, participants will complete assessments to measure the feasibility of telehealth music therapy, defined by completing at least 9 of the 12 sessions. Researchers will monitor cognitive function, mood symptoms, and fatigue. Participants must be able to complete study assessments independently and consent in English. The total study duration includes the intervention period and follow-up assessments to evaluate outcomes related to cancer-related cognitive dysfunction.

Researchers are evaluating the safety, tolerability, and maximum tolerated dose of BPI-371153, a PD-L1 inhibitor, in patients with advanced solid tumors or relapsedrefractory lymphoma. This phase 1 open-label study aims to establish the recommended dose for further research and to understand how the drug behaves in the body and its anti-tumor activity. Participants will receive oral capsules of BPI-371153 once daily in 21-day treatment cycles. The study includes a dose escalation phase to find the maximum tolerated dose and a dose expansion phase where patients receive the recommended dose. Different patient groups include those with advanced non-small cell lung cancer, relapsed or refractory lymphoma, hepatocellular carcinoma, and other advanced solid tumors. During the study, participants will be monitored for adverse events, drug levels in the body, and tumor response over approximately 24 months. Researchers will assess tumor lesions using recognized criteria and evaluate PD-L1 expression levels. The study requires adequate organ function and performance status, with ongoing evaluation to ensure safety and determine the best dose for future studies.

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 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 the safety and early effectiveness of TT-01488, an oral tablet that reversibly inhibits BTK, in adults with B-cell malignancies who have not responded to or tolerated previous treatments. This open-label Phase I study aims to find a suitable dose for further testing and to assess how the drug behaves in the body. The study is sponsored by TransThera Sciences Nanjing, Inc. The trial has two parts a dose escalation phase where TT-01488 tablets are given once daily in 28-day cycles at increasing doses to find the recommended dose for expansion followed by a dose expansion phase where this dose is further tested for safety and early effectiveness. The dose escalation uses a modified 33 design starting at 50 mg daily, with the goal of identifying a recommended Phase II dose based on safety, drug levels, and response. Participants will take daily tablets and undergo assessments including monitoring for dose-limiting toxicities within 28 days of the first dose, along with safety and response evaluations over three years. Researchers will track adverse events, drug concentration in the blood, and measures like disease control and survival. The study is non-randomized and open-label, and participant involvement may last up to three years depending on outcomes and follow-up needs.