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 NK/T-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 studying the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging in patients with cancer. This phase I trial aims to evaluate how well FLT PET imaging measures tumor growth and the activity of the DNA synthetic pathway in various cancers, including solid tumors and blood cancers. The study also seeks to determine how effective this imaging method is at detecting lesions and assessing response to treatment. Participants receive up to four FLT PET imaging procedures. During each procedure, a small amount of the FLT tracer compound is injected into the vein, followed by PET scan data collection for two hours to measure tumor growth. Blood samples may be taken during the scans, and urine samples collected afterward to analyze breakdown products of the tracer. Throughout the study, patients undergo assessments including PET or CT PET scans to measure tracer uptake and retention in tumors and normal organs. Researchers also evaluate changes in key enzymes related to DNA synthesis before and after therapy. These evaluations help monitor tumor activity and treatment response. The total time participants spend in the scanner during imaging is up to two hours per session, with a focus on capturing detailed tumor growth information.

Researchers are evaluating a new universal CAR T cell therapy called 4SCAR19U for patients with CD19-positive B cell malignancies. This phase I trial aims to assess the feasibility, safety, and effectiveness of these specially engineered T cells. The study also seeks to understand how well the 4SCAR19U T cells function and how long they remain active in patients. This approach may offer a faster, more cost-effective alternative to traditional CAR T therapies, especially for patients with weakened immune systems or rapidly progressing disease. The treatment involves infusing patients with universal CD19-specific CAR gene-engineered T cells known as 4SCAR19U cells. These cells are manufactured in bulk and ready to use off-the-shelf, avoiding the long preparation time required for patient-specific therapies. This immediate availability aims to provide timely treatment to patients who need it urgently. The trial is conducted at multiple clinical centers and includes one experimental group receiving the 4SCAR19U cell infusion. Participants will be monitored closely for safety over 24 weeks following the infusion, with evaluations of adverse effects and overall health. The study will also track the anti-tumor activity of the 4SCAR19U cells for up to one year after treatment. Assessments include physical exams, blood tests, and other clinical evaluations to understand the treatment's impact and cell persistence. The total duration of involvement varies, with long-term follow-up to gather important safety and effectiveness data.

Researchers are evaluating a new formulation of 64Cu-LLP2A, a drug used with PET/CT imaging, to study its dosimetry and imaging quality in healthy volunteers and patients with certain blood cancers. These cancers include multiple myeloma and various low-grade lymphomas. This early phase 1 study aims to confirm that the new formulation provides similar human dosimetry to previously published results and to expand evaluation to patients with confirmed diagnoses or those post bone marrow transplant with suspected recurrence. Participants will receive 64Cu-LLP2A followed by PET/CT imaging at up to three separate times depending on the injection day of the week. Imaging sessions involve multiple quick body scans within the first hour, additional scans between 120 to 240 minutes, and a later scan 15 to 28 hours post injection. Patients with known lesions will have dynamic imaging centered over those areas for one hour, plus an additional scan from head to upper thigh after injection. During the study, participants will undergo PET/CT scans and monitoring of organ dosimetry and safety for up to seven days after 64Cu-LLP2A administration. Researchers will assess the quality of PET images by looking at bone marrow uptake and tumor-to-background ratios. Safety will be tracked by recording any adverse events. The total imaging and evaluation period is estimated to last up to two days, with additional follow-up phone assessments.

Researchers are studying the use of [90Y]Y-PentixaTher ([90Y]Y-PTT) to treat patients with recurrent or refractory primary or isolated secondary central nervous system (CNS) lymphoma. This open-label, single-arm phase 1/2 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 [90Y]Y-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 (r/r 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 × 10^8 to 1.2 × 10^9 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 CT1182's 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 treatment's 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.