Non-Hodgkin Lymphoma

This research aims to evaluate the effectiveness and safety of a combination treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NKT-cell lymphoma. The study is designed as a Phase 1 and Phase 2 clinical trial and focuses on improving local disease control and overall prognosis in this specific type of lymphoma. Patients receive an oral regimen combining Selinexor, Pegaspargase, and Dexamethasone. Selinexor works by inhibiting nuclear export proteins that are overexpressed in malignant tumor cells, including viral mRNA such as EBV. This treatment is combined with sequential radiotherapy to potentially enhance outcomes. The study monitors the responses to this combined therapy in early-stage lymphoma. Participants will be involved in regular assessments to track tumor response and overall health. The primary outcome measured is the complete response rate CRR based on tumor volume reduction, evaluated up to 36 months from randomization. Safety and treatment effects will be closely monitored during the trial period, which runs from September 2024 through December 2026.

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 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.

Researchers are evaluating the safety, effectiveness, and cellular metabolism of CT1190B CAR-T cell therapy in adults with relapsed or refractory B-cell Non-Hodgkin lymphoma B-NHL. This Phase 1, open-label study aims to understand how CT1190B cells behave in the body and impact the disease. The trial plans to enroll between 6 and 24 participants who have previously undergone treatment for B-NHL but need further therapy due to disease progression or intolerance to prior treatments. Participants will receive an infusion of CT1190B CAR-T cells designed to target their cancer. This single-arm study involves one treatment group receiving this experimental therapy. The study includes close monitoring for adverse events and determination of the maximum tolerated dose within 28 days after infusion. Follow-up evaluations will continue for up to 12 months to assess response rates, remission duration, survival outcomes, and other key measures. During the trial, participants will undergo regular assessments including physical exams, laboratory tests, and imaging to measure tumor response and monitor safety. Researchers will track overall response rate, complete remission rate, progression-free survival, and overall survival at various intervals up to one year. Participants are required to agree to long-term follow-up for up to 15 years to monitor ongoing effects. Total involvement includes the treatment period plus extended safety and outcome monitoring.

Researchers are evaluating the safety, effectiveness, and cellular metabolism of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL. This is an early-phase, single-arm, open-label clinical study enrolling between 6 and 24 participants to explore how these specialized immune cells behave and impact the disease. Participants will receive an infusion of CT1190B CAR-T cells as the experimental treatment. The study focuses on assessing the dose range and safety within 28 days after infusion. It includes monitoring overall response and remission rates at 4 weeks, 8 weeks, 12 weeks, and then at 6, 9, and 12 months post-infusion. During the study, participants will undergo regular evaluations including safety assessments for adverse events up to 12 months after infusion. Researchers will monitor response times, duration of remission, progression-free survival, and overall survival over one year. Long-term follow-up is planned for up to 15 years to gather extended safety and efficacy data. Participants will be closely observed through scheduled visits and tests throughout the study period.

Researchers are evaluating the safety, efficacy, and cellular metabolism of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL. This clinical study is a single-arm, open-label, dose exploratory trial designed to enroll between 6 and 24 participants. It aims to assess how these CAR-T cells behave and affect the disease in this patient population under medical supervision. Participants will receive infusions of CT1190B and CT1190B-P cells as the experimental treatment. The study does not include a comparison group and focuses on evaluating the dose range and maximum tolerated dose within 28 days after infusion. The treatment involves a single-arm administration of chimeric antigen receptor T cells, and participants will be followed for up to 12 months to monitor responses and safety outcomes. Throughout the study, participants will undergo various assessments including monitoring of the dose effects, overall and complete response rates at multiple time points 4, 8, 12 weeks and 6, 9, 12 months, duration of remission, progression-free survival, and overall survival up to 12 months after treatment. Participants must adhere to a long-term follow-up plan extending up to 15 years as required by regulatory guidelines. Safety evaluations and cellular pharmacokinetics will also be monitored during the study period.

Researchers are evaluating CT1182, an in vivo CAR-T cell therapy, in patients with relapsed or refractory B-cell Non Hodgkin Lymphoma rr B-NHL. This early phase 1, open-label study aims to explore the safety, effectiveness, metabolic behavior, and pharmacodynamics of CT1182 cells. The study intends to identify the maximum tolerated dose MTD by testing four dose levels, with a target toxicity probability of 30%, to understand how the treatment affects patients with various subtypes of B-NHL. Participants will receive intravenous infusions of CT1182 at escalating dose levels ranging from 1.2 108 to 1.2 109 TU. The dose escalation follows a Bayesian Optimal Interval design, with safety monitored over a 28-day dose-limiting toxicity DLT observation period after the first infusion. If no DLT is observed, doses may be adjusted if ineffective expansion of CAR-T cells is detected, early withdrawal or continued safety observation is possible. The study plans to enroll between 3 and 24 participants, with dosing and cohort size adjusted according to ongoing results. During the study, participants will be closely monitored for adverse events, DLTs, and response rates for up to 24 months after infusion. Evaluations include clinical assessments, laboratory tests, and measurement of CAR gene copy numbers at multiple timepoints. Outcome measures include safety profiles, objective and complete response rates, duration and time to remission, progression-free survival, overall survival, and metabolic kinetics of the lentiviral vectors used in treatment. The study follows participants through long-term safety and efficacy assessments to better understand CT1182s impact.

Researchers are evaluating the safety and effectiveness of an investigational treatment called RN1101, which are allogeneic CAR-T cells targeting CD19 and BCMA. This early-phase, open-label pilot study focuses on patients with relapsed or refractory B-cell or plasma cell-derived malignant tumors, including B-cell lymphoma and multiple myeloma. The study plans to enroll 21 patients to understand how well this treatment works and its safety profile for these challenging cancers. Participants will receive a single intravenous infusion of RN1101 cells designed to target and attack cancerous B cells or plasma cells. The study involves a dose-escalation approach where all patients receive the experimental therapy. Researchers will monitor the treatments ability to reduce or eliminate cancer cells expressing CD19 or BCMA and evaluate how long these CAR-T cells persist in the body. Throughout the study, participants will be closely followed for up to 24 weeks after the infusion. Researchers will assess safety by tracking adverse events and measure effectiveness using outcomes such as minimal residual disease status, response rates, progression-free survival, overall survival, and CAR-T cell presence in blood and bone marrow. Blood tests, imaging, and clinical evaluations will be performed regularly to monitor treatment response and participant health over this period.

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.