B-Cell Malignancy

Multiple myeloma MM is a type of blood cancer that currently has no cure and often returns after treatment, leading to a survival time of about 5 to 8 years after diagnosis. Researchers are studying whether a new imaging substance called 18F-fluciclovine can detect MM more effectively than the currently used 18F-FDG. This trial is a phase 2 study focused on adults with MM, including those newly diagnosed or with relapsedrefractory disease, aiming to improve early detection of returning disease. Participants will receive an injection of the radiotracer 18F-fluciclovine and undergo PETCT scans at three different times initially, after treatment for newly diagnosed participants or six months for relapsedrefractory participants, and at disease progression or after 5 years. Each visit includes two PETCT scansone with 18F-FDG and one with 18F-fluciclovineas well as an optional MRI scan and a bone marrow biopsy. The study compares the imaging results from both tracers to assess which better detects MM lesions. During the study, participants will attend three visits where tests and scans will be performed, possibly spread over 30 days per visit. Blood tests, imaging scans, and bone marrow samples will help researchers measure disease volume, minimal residual disease, and response to treatment. Safety of the new radiotracer is also monitored shortly after each dose. Participation may last up to 5 years, with follow-up visits scheduled to track disease progression and imaging results.

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 a new formulation of 64Cu-LLP2A, a drug used for PETCT imaging, in both healthy volunteers and patients with blood cancers such as multiple myeloma and low-grade lymphoma. This early phase study aims to confirm that the new formulation provides comparable human dosimetry to the previous formulation while expanding the patient population to include those with confirmed diagnoses or those who have undergone bone marrow transplant with suspected disease recurrence. Participants will receive the 64Cu-LLP2A drug followed by PETCT imaging at up to three different time points depending on the day of injection. Imaging includes multiple quick body scans shortly after injection, scans at 120-180 or 180-240 minutes post-injection, and a delayed scan 15-28 hours later. Some participants will also undergo a dynamic PETCT scan focused on a known target lesion for 60 minutes, followed by an additional whole-body scan. During the study, participants will be monitored for organ dosimetry and safety through adverse event tracking up to 7 days after administration. The quality of PET images will be assessed based on overall image quality, bone marrow uptake, and tumor-to-background ratios. Participants must lie still within the scanner for up to 75 minutes during imaging sessions. The study is expected to complete by March 2027.

Researchers are evaluating the use of BCMA-targeted positron emission tomographycomputed tomography PETCT scans in patients with multiple myeloma and related plasma cell disorders. This prospective, multicenter diagnostic imaging study aims to visualize and measure BCMA expression throughout the body, helping to detect active disease and its variations. The study focuses on how this imaging method may provide valuable clinical information across different disease states. Participants will receive the 68Ga-labeled BCMA PETCT imaging through an intravenous injection of a BCMA-targeted radiotracer followed by a whole-body scan following a standardized protocol. Imaging results will be compared with biopsy findings when possible to assess accuracy. The study will also explore relationships between PETCT findings and other clinical, laboratory, and imaging markers, including minimal residual disease assessments. Some participants will have blood samples taken to measure circulating soluble BCMA levels, providing additional biological context. During the study, participants will undergo the PETCT imaging and may have biopsies and blood tests as part of assessments. Researchers will analyze imaging findings alongside clinical and laboratory data to understand disease burden and response. Safety of the radiotracer will be monitored for up to 30 days after injection. Follow-up will assess changes in imaging over time and the impact on clinical management. The study is expected to last until December 2027 and includes adults aged 18 to 80 years.

Researchers are studying the use of 90YY-PentixaTher 90YY-PTT to treat patients with recurrent or refractory primary or isolated secondary central nervous system CNS lymphoma. This open-label, single-arm phase 12 study aims to evaluate the safety, tolerability, biodistribution, and preliminary effectiveness of this treatment. The study includes three dose-level groups, and a safety review committee will carefully monitor for any dose-limiting side effects to guide dose adjustments. Participants will receive one cycle of 90YY-PTT administered intravenously. The study follows a best-of-5 dose escalation design across three cohorts with different dose levels. There is no comparison group in this study. After the treatment, patients will undergo several visits during the core study phase to assess safety, how the drug spreads in the body, dosimetry, and treatment response. Following this, three follow-up visits will occur at three-month intervals to monitor disease status. Throughout the study, participants will be closely monitored for adverse events, with severity graded by standard criteria. Various imaging and laboratory tests will be performed shortly after infusion and at multiple time points to measure drug uptake in tumors and organs, blood levels, and absorbed radiation doses. Researchers will assess response rates, progression-free survival, and overall survival at one, three, six, nine, and twelve months after treatment. The total study duration includes screening, treatment, core evaluations, and extended follow-up visits to comprehensively evaluate treatment outcomes and safety.

This observational study aims to create a national registry in Italy for multiple myeloma to monitor routine clinical practice and describe the standard care used for diagnosis and treatment. Multiple myeloma accounts for a small percentage of tumor diagnoses in Italy, with incidence rates of 9.5 per 100,000 males and 8.1 per 100,000 females. The registry will help analyze current treatment patterns and patient demographics to address future changes in care. The study involves a non-interventional, multicenter registry collecting both retrospective and prospective data from patients diagnosed with multiple myeloma since January 1, 2019. Data will be gathered using an electronic platform, and patients will be enrolled consecutively during their regular appointments after providing informed consent. Patients participating in other studies can also be included, with baseline and survival data collected for those in interventional trials. Participants will have hospital visits every six months, where clinical data and patient-reported outcomes will be recorded. Researchers will assess overall survival and time to next treatment over three years, along with patient-reported outcomes and costs incurred by patients. The study provides long-term monitoring without altering patients usual care, and participation duration may vary depending on individual follow-up.

Researchers are evaluating the safety and effectiveness of BCMA-targeted prime CAR-T cell therapy in patients with relapsed or refractory Multiple Myeloma and other plasma cell diseases. This study focuses on patients who have limited treatment options and aims to assess adverse events and disease response after receiving this targeted therapy. Participants will receive a single treatment of BCMA-targeted prime CAR-T cells designed to attack myeloma cells expressing BCMA. The study includes Phase 1 and Phase 2 components and monitors patients for up to two years to evaluate treatment response and safety. During the study, participants will undergo regular assessments including monitoring of adverse events, disease status, levels of BCMA-targeted CAR-T cells in blood and bone marrow, clonal plasma cell quantities, serum IL-6 levels, and survival outcomes. The total follow-up duration for outcome measurement is up to two years to observe treatment effects and patient safety over time.

Researchers are evaluating the effectiveness and safety of CD19 and CD22 targeted prime CAR-T cell therapy for patients with relapsed or refractory B-cell acute lymphoblastic leukemia B-ALL. This study addresses patients who have not responded to previous anti-CD19 CAR-T treatments or who have experienced relapse without CD19 expression. The goal is to improve outcomes for these patients using a new targeted CAR-T cell approach. Participants will receive a single intravenous infusion of CD19 and CD22 targeted prime CAR-T cells as the experimental treatment. This single-arm study involves no placebo or comparison group. The therapy targets both CD19 and CD22 proteins on leukemia cells to potentially overcome resistance seen with prior treatments. During the study, participants will be closely monitored for adverse events related to the treatment for up to two years. Researchers will assess the response rate to the CAR-T therapy over six months and track various measures such as CAR-T cell presence in bone marrow and blood, immune factors like IL-6 and TNF-alpha, and survival outcomes. Patients will have regular visits and evaluations to ensure safety and to collect data on the therapys effects.

Researchers are evaluating TQB2934, a special antibody designed to target multiple myeloma, a cancer affecting plasma cells. This antibody binds to T cells and cancer cells to activate the immune system to attack the disease. The study is a Phase 1 clinical trial focusing on safety and the bodys handling of the drug in patients with malignant plasma cell tumors. The study involves giving TQB2934 as a subcutaneous injection at doses of 40mg or 60mg. Treatment cycles occur once weekly during the first three cycles, then every two weeks for cycles four to six. If patients achieve a partial remission or better after six cycles, dosing continues every four weeks. Each treatment cycle lasts 28 days. Participants will undergo various assessments including blood tests to measure drug levels and immune response over 120 hours after each dose. Researchers will monitor adverse events for up to 24 months and evaluate treatment responses such as remission rates and survival outcomes. The total study participation includes treatment and long-term safety follow-up lasting up to two years.

Researchers are studying the safety and effectiveness of GT801 injection in adults who have relapsed or refractory CD19-positive B-cell blood cancers, including acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkins lymphoma, and autoimmune hemolytic anemia. This early phase 1 study aims to understand how well the treatment works and its side effects in this group of patients. Participants will receive the GT801 injection as the study treatment. The study focuses on one group receiving this intervention. The treatment schedule and dosing details are not specified, but safety and response to the treatment will be monitored over a period of time, including up to 12 months after infusion. During the study, participants will be closely monitored for side effects and treatment responses through various assessments. Researchers will measure the proportion of participants experiencing dose-limiting toxicity within 28 days and track adverse events up to 3 months after infusion. They will also evaluate overall response rates, duration of response, progression-free survival, and other outcome measures related to both the blood cancers and autoimmune hemolytic anemia for up to 12 months. The study includes regular follow-up visits and evaluations to gather this information.