Search

The University of Kansas Medical Center conducted a study on the successful use of a midline catheter for leukapheresis in patients undergoing collection for immune effector cell therapy. The research showed that apheresis through a midline catheter was feasible and effective in most populations, potentially reducing the need for central venous catheter access. This study, published in the Journal of Clinical Apheresis, highlights the importance of utilizing limited healthcare resources efficiently in cellular therapy procedures. [Extracted from the article]

The article discusses an Expanded Access Program (EAP) for Obecabtagene Autoleucel (obe-cel) for adult patients with Acute Lymphoblastic Leukemia (ALL) whose treatment product is deemed out-of-specification (OOS). The program aims to provide access to obe-cel for patients with limited treatment options and describes the safety profile of obe-cel within the first 45 days after infusion. The study is a single-arm, open-label, multicenter EAP for adult patients diagnosed with recurring or refractory ALL. Patients must meet specific eligibility criteria to participate in the study, and data will be collected from routine medical records for analysis. [Extracted from the article]

A clinical trial, NCT06768905, is being conducted to assess the safety, efficacy, and tolerability of a single 50 mCi dose of 131I-Apamistamab followed by axicabtagene ciloleucel infusion in patients with Relapsed or refractory (R/R) Diffuse large B-cell lymphoma (DLBCL). The study involves a 6-patient safety run-in to evaluate safety measures. The trial aims to determine the impact of this treatment regimen on patients with DLBCL, with a primary completion date set for May 31, 2028. [Extracted from the article]

The article discusses a clinical trial, NCT06759181, evaluating the efficacy and safety of Anti-BCMA/FcRL5 CAR-T cells in patients with relapsed and refractory multiple myeloma. The study involves a leukapheresis procedure to manufacture the modified T cells, followed by lymphodepleting therapy with fludarabine and cyclophosphamide before infusion. The trial aims to assess outcomes such as adverse events, overall response rate, complete response, overall survival, and event-free survival over a period of 24 months. The study is recruiting participants in China and is expected to be completed by December 31, 2027. [Extracted from the article]

The article discusses a Phase I/II clinical trial, NCT06762431, evaluating the safety and efficacy of concomitant therapy with anti-CD19 CAR T-cells and Lenalidomide in adult patients with relapsed/refractory chronic lymphocytic leukemia (CLL). The trial involves pretreating patients with Ibrutinib for 3 months prior to leukapheresis, followed by lymphodepleting chemotherapy and infusion of CAR T-cells at fixed dose levels, along with Lenalidomide intake. The study aims to explore safety, tolerability, pharmacokinetics of CAR-T cells, overall response rate, duration of response, progression-free survival rates, overall survival rates, and MRD negativity rates. The trial is currently enrolling participants in Belarus. [Extracted from the article]

A recent study conducted by Massachusetts General Hospital and Harvard Medical School introduced a new method for analyzing circulating tumor cells (CTCs) in blood samples, which can provide valuable insights into cancer progression. By utilizing a high-throughput microfluidic device, researchers were able to enrich CTCs from large blood volumes, revealing significant intra-patient heterogeneity and subclonal patterns of aneuploidy and distinct signaling pathways within CTCs. This innovative approach enables comprehensive monitoring of cancer through cell-based liquid biopsy, offering potential benefits for cancer diagnosis and treatment. [Extracted from the article]

Researchers have submitted a patent application for a method to generate genetically modified natural killer (NK) cells for cancer therapy. The method involves enriching NK cells from a sample, introducing genetic modifiers through electroporation and transduction, and expanding the modified NK cells. This approach aims to enhance the therapeutic potential of NK cells in clinical applications by introducing transgenes into their genome. The patent application highlights the importance of optimizing the timing and methods of genetic modification to improve the efficiency and functionality of gene-modified NK cells. [Extracted from the article]

Researchers from Amrita Vishwa Vidyapeetham in India conducted a study to determine the feasibility of establishing a CAR-T cell therapy center in a resource-limited setting to treat relapsed or refractory B-cell malignancies. The study involved treating 8 patients with a median age of 38 years, with most patients needing to raise funds for their treatment through crowdfunding. Despite challenges such as high costs and resource constraints, the therapy was effectively implemented, showing potential for similar environments. The study concluded that while there were limitations in the data, the results highlight the therapy's promise in resource-constrained settings. [Extracted from the article]

A recent study conducted at Washington University School of Medicine focused on reducing relapse rates in pediatric and young adult patients with high-risk AML after haploidentical transplant. The study involves the adoptive transfer of novel NK cell products following TCRab T cell depleted haplo-HCT, aiming to enhance graft versus leukemia effects without causing graft-versus-host disease. The primary objective of the study is to assess the safety and feasibility of this approach, with secondary objectives including estimating relapse-free survival and defining donor NK cell expansion and interactions with other immune populations. The study is expected to be completed by April 2027 and is registered at clinicaltrials.gov. [Extracted from the article]

A recent study conducted at the University of Minnesota Medical Center focused on developing a new treatment for hemophilia B called BE-101. This treatment involves genetically engineering B lymphocyte lineage cells to express and secrete Factor IX, aiming to restore clinically meaningful levels of the protein in adults with moderately severe or severe hemophilia B. The study, known as BeCoMe-9, is a Phase 1/2 clinical trial that aims to evaluate the safety and efficacy of BE-101 through a dose-escalation and expansion approach. Researchers hope that this new treatment could offer durable and tunable therapeutic effects for individuals with hemophilia B. [Extracted from the article]

A study conducted at Mayo Clinic examined the correlation between pre-apheresis biomarkers and the development of severe cytopenias and therapy-related myeloid neoplasms in non-Hodgkin lymphoma patients undergoing chimeric antigen receptor T-cell therapy. The research identified factors such as age, platelet count, ferritin levels, and LDH as associated with prolonged cytopenia, while advanced age, anemia, high ferritin levels, and a history of three lines of therapy were linked to the development of therapy-related myeloid neoplasms. These findings could potentially aid in patient counseling and therapy selection by identifying those at high risk of hematotoxicity and myeloid neoplasm development. [Extracted from the article]

A recent study conducted at Vanderbilt University Medical Center examined the impact of patient distance from the center on outcomes and costs for individuals undergoing Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma. The study found that longer distances from CAR-T centers may be associated with inferior infection and survival outcomes. Patients who lived more than 90 miles from the center experienced higher non-relapsed mortality and infection-related deaths. The research suggests the need for future multicenter studies to address barriers to access and supportive care for patients undergoing CAR-T therapy. [Extracted from the article]

The research from the Weizmann Institute of Science in Israel focuses on using single-cell analysis to predict outcomes of CAR-T cell therapy in patients with Diffuse Large B-Cell Lymphoma. By analyzing peripheral blood samples, researchers identified specific cellular and molecular features associated with treatment response. The study found that patients with high B-cells in their blood at the time of leukapheresis achieved complete remission, while non-responders showed enrichment of specific myeloid cell populations. The findings suggest potential biomarkers for predicting treatment response and improving personalized therapy for high-risk patients. [Extracted from the article]

The article discusses a clinical trial, NCT06708936, evaluating the safety, tolerability, and preliminary efficacy of KSD-201 in patients with advanced clear cell renal cell carcinoma. The study involves a single-center, single-arm, open-label design with two phases: dose-limiting toxicity observation and an expansion study. Patients will receive KSD-201 via subcutaneous injections, and outcomes will include immune response, clinical efficacy, and quality of life assessments. The trial aims to contribute to the understanding of treating advanced clear cell renal cell carcinoma. [Extracted from the article]

The article discusses a phase I/II clinical trial, NCT06704269, focusing on the safety, efficacy, and cellular kinetics of YTB323, a Biological CAR-T cell therapy, in participants with treatment-resistant generalized myasthenia gravis. The study aims to enroll approximately 15 participants with treatment-resistant gMG, utilizing a single-dose design across two cohorts. The primary outcome measures include assessing adverse events, pharmacokinetics of YTB323, immunogenicity, and changes in MG-ADL and QMG scores. The trial is not yet recruiting participants and is expected to be completed by August 2, 2029. [Extracted from the article]

The article focuses on the challenges of managing raw material variability in autologous cell therapies, highlighting the significant impact of patient-to-patient differences and variations in collection and manufacturing processes on the quality, safety, and efficacy of the final cell therapies. It emphasizes the need for strategies such as standardized protocols, automation, and process analytics to address these challenges.

Cryoport, Inc. has opened a new IntegriCell facility in Villers-le-Bouillet, Liege, Belgium, to support the development and commercialization of cell-based therapies. This standardized bioprocessing and cryopreservation solution aims to enhance manufacturing efficiency and product stability for cell therapies. The facility has the capacity to cryopreserve over 1,100 leukapheresis products annually, providing high-quality cryopreserved leukopaks for cell-based therapy programs. CEO Jerrell Shelton highlights the facility's role in delivering consistent cryopreservation solutions to the cell therapy community and supporting the efficient delivery of transformative therapies to patients. [Extracted from the article]

A recent study conducted at Bharti Vidyapeeth Deemed University Medical College in Maharashtra, India, focused on donor parameters affecting platelet yield during plateletpheresis. The research found a significant positive correlation between platelet yield and body mass index (BMI), total leukocyte count (TLC), and platelet count, while mean platelet volume (MPV) showed a negative correlation. The study concluded that considering donor parameters such as pre-donation platelet count, BMI, TLC, and MPV is crucial for recruiting donors for single-donor platelet procedures to improve platelet yield. [Extracted from the article]

A study conducted at SMS Medical College and Hospital in Rajasthan, India, analyzed changes in serum calcium and magnesium levels in healthy plateletpheresis donors using different apheresis machines. The research found that there was a significant decline in serum calcium and magnesium levels during the procedure, with the most significant decline observed in the Hemonetics MCS+ machine. However, these levels returned to normal within 30 minutes after the completion of the procedure, indicating that plateletpheresis is a well-tolerated and safe process for donors. The study included 137 donors, with 14.60% experiencing adverse reactions. [Extracted from the article]

The article discusses a phase II clinical trial comparing the effects of folate receptor alpha dendritic cells (FRaDCs) to a placebo in treating patients with advanced stage ovarian cancer. FRaDCs are a type of dendritic cell vaccine made from a person's white blood cells and target a protein found in high levels on ovarian tumor cells. The trial aims to evaluate the efficacy of FRaDCs in preventing or delaying recurrence in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer. The study is set to be completed by December 31, 2027, and focuses on outcomes such as recurrence-free survival and overall survival in patients receiving FRaDCs compared to a placebo. [Extracted from the article]

A study conducted at the Mayo Clinic in Jacksonville, Florida, focused on the outcomes of patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who underwent anti-CD19 chimeric antigen receptor T-cell therapy (CART). The study examined the impact of bridging treatment with radiotherapy on relapse-free survival, event-free survival, and overall survival. Results showed that patients who received bridging radiotherapy had higher response rates, improved local control, and better survival outcomes compared to those who did not receive radiotherapy. The research concluded that radiotherapy before CART for patients with limited disease sites improves outcomes without significant toxicities. [Extracted from the article]

A study conducted at Ghent University in Belgium examined the impact of early initiation of antiretroviral therapy (ART) during acute HIV infection (AHI) on immunovirological outcomes. The study collected longitudinal clinical data and human bodily material (HBM) from participants diagnosed and treated during AHI. The findings showed that early initiation of ART during AHI had a beneficial effect on long-term immunovirological outcomes, regardless of the stage of infection at treatment initiation. The study also demonstrated that collecting HBM during and after AHI was safe and feasible. The researchers emphasized the importance of comprehensive cohorts that integrate clinical data with high-quality HBM samples to study the impact of early ART on reservoir dynamics and immune responses across various anatomical sites after AHI. [Extracted from the article]

The Memorial Sloan Kettering Cancer Center is conducting a Phase I clinical trial, NCT06623396, to investigate the safety and effectiveness of intraperitoneal mesothelin-targeted CAR T-cell therapy in patients with mesothelin-positive esophagogastric adenocarcinoma with peritoneal carcinomatosis. The trial aims to enroll 18 participants who will have their white blood cells collected and modified in the laboratory to become MSLN-targeted CAR T cells. The therapy will be administered over a 3-4 week period. The document provides detailed criteria for inclusion and exclusion in the trial, including timeframes for obtaining tissue samples and medical conditions that would prevent enrollment. The study is open to individuals of all genders aged 18 years and older. Administrative information, such as the study ID number and data sharing plan, is also included. [Extracted from the article]

A study conducted at Oslo University Hospital in Norway examined the management of hyperleukocytosis in pediatric acute myeloid leukemia (AML). The researchers recommended immediate initiation of full-dose chemotherapy using etoposide monotherapy without leukapheresis or prephase chemotherapy. The study found that this approach was feasible, safe, and effective, with a reduction in white blood cell count comparable to leukapheresis. The five-year event-free and overall survival rates for patients with hyperleukocytosis were slightly lower than those without hyperleukocytosis. The researchers concluded that early initiation of induction chemotherapy is crucial for managing hyperleukocytosis in pediatric AML. [Extracted from the article]

Researchers from Universite Paris Cite have published a study on the use of neurofilament light chain (NfL) levels as a predictive biomarker for neurotoxicity after CAR T-cell therapy. The study found that elevated NfL levels at the time of CAR T-cell infusion were associated with the severity of immune effector cell-associated neurotoxicity syndrome (ICANS). The researchers concluded that incorporating NfL levels into the decision-making process could help guide the management of ICANS and determine the appropriate CAR product for each patient. This research provides valuable insights for the development of personalized treatments for patients undergoing CAR T-cell therapy. [Extracted from the article]

Global Life Sciences Solutions USA LLC has been issued a patent for an apparatus for fluid line management in a bioprocessing system. The invention relates to the production of cellular immunotherapies, specifically chimeric antigen receptor (CAR) T cell therapy. The system aims to reduce contamination risk by increasing automation and decreasing human handling, while also providing flexibility and consistency in volume production. The patent describes the components and features of the system, including a tray, pump assembly, pinch valve array, and tubing module. [Extracted from the article]

A clinical trial has been launched to investigate the potential cure of HIV infection in patients who have undergone a stem cell transplant. The trial involves closely monitoring patients whose blood shows no detectable levels of the HIV virus after leukapheresis, a process of collecting blood. These patients will discontinue their antiretroviral therapy (ART) and be regularly tested and monitored for up to 52 weeks. If they remain HIV-free during this period, they may be considered cured of their HIV infection. The trial is currently in the recruitment phase and aims to enroll 10 participants. [Extracted from the article]

This document provides information about a clinical trial in China, NCT06567366, which is investigating the use of a drug called Glofitamab in combination with CAR T-cell therapy for the treatment of large B-cell lymphoma. The trial aims to evaluate the efficacy and safety of this treatment option and will assess various outcome measures such as response rates, duration of response, and survival rates. The trial is currently in the interventional phase and is designed as a single-group trial with the primary purpose of treatment. Eligible participants must have relapsed or refractory lymphoma and meet certain prognostic factors. The trial is not yet recruiting participants, and it is projected to be completed in September 2027. [Extracted from the article]

The article focuses on a clinical trial assessing the safety, side effects, and optimal dosage of the drug NEXI-001 combined with decitabine and lymphodepleting chemotherapy for treating relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) following allogeneic hematopoietic cell transplantation. It explains that the study aims to determine the recommended dose and evaluate the treatment's anti-leukemic activity, including response rates and survival outcomes.

The article focuses on a Phase 2, open-label, randomized clinical trial evaluating the combination of pirtobrutinib and brexucabtagene autoleucel in patients with relapsed or refractory mantle cell lymphoma. Topics include the study design and goals, which involve assessing progression-free survival and comparing the efficacy and safety of concurrent pirtobrutinib versus no concurrent pirtobrutinib, as well as the secondary outcomes related to severe adverse events and overall response rates.

A recent study conducted at Zhongnan Hospital of Wuhan University explored the use of leukapheresis, a procedure that reduces white blood cell count, in patients with hyperleukocytic acute myeloid leukemia. The study found that leukapheresis treatment resulted in a significant decrease in white blood cells and a decrease in infection rates compared to non-apheresis treatment. However, the study also noted that leukapheresis treatment can be damaging to cells and that the optimal centrifugation parameters need to be determined to minimize cell damage. The research concluded that the cells obtained under the optimal centrifugation parameters can be successfully cryopreserved and used to establish leukemia animal models, which can improve the efficiency and reduce the side effects of leukapheresis. [Extracted from the article]

A study conducted at Osmangazi University in Turkey examined the effects of plateletpheresis, a procedure used in blood transfusions, on platelet function, coagulation, and fibrinolysis. The researchers measured platelet activation, platelet-leukocyte aggregates, and coagulation activation in donors. The study found that plateletpheresis increased levels of platelet-monocyte and platelet-neutrophil complexes, indicating platelet activation, but did not result in coagulation activation. These findings suggest that plateletpheresis affects platelet function but does not cause changes in the coagulation system. The study was published in the journal Clinical Hemorheology and Microcirculation. [Extracted from the article]

A recent study conducted at the University of Houston explores the potential of microfluidic cell separation methods to enable centrifugation-free, low extracorporeal volume (ECV) leukapheresis in pediatric patients. Leukapheresis is a procedure used to remove white blood cells from a patient's blood. The study highlights the challenges and advancements in passive separation methods and discusses their potential for future use as a high-throughput microfluidic leukapheresis platform. The research was supported by the NIH National Heart Lung & Blood Institute (NHLBI) and has been peer-reviewed. [Extracted from the article]

A recent report from University Hospital Vall d'Hebron in Barcelona, Spain, discusses the use of bendamustine-containing regimens as bridging therapy (BT) for patients with relapsed/refractory large B-cell lymphoma (LBCL) who are receiving chimeric antigen receptor (CAR) T-cell therapy. The study aimed to assess the impact of bendamustine on CAR-T outcomes and found that BT with bendamustine-containing regimens was safe and did not negatively affect CAR-T efficacy or patient survival. The research suggests that bendamustine can be a potential option for BT in these patients. The study was supported by Instituto de Salud Carlos III, Asociacion Espanola contra el Cancer, and Generalitat de Catalunya. [Extracted from the article]

This document provides information about a clinical trial in China for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). The trial is studying the use of a biological treatment called Relma-cel, which involves the administration of CAR+T cells. The study aims to evaluate the effectiveness, safety, and pharmacokinetics of Relma-cel in LBCL patients. The trial is currently in the interventional phase and is expected to be completed by April 2025. [Extracted from the article]

This document provides information about an ongoing clinical trial conducted by Tianjin Medical University Cancer Institute and Hospital in China. The trial, with the NCT number NCT06484790, aims to evaluate the safety and effectiveness of autologous TCR-T cell therapy in individuals with advanced solid tumors. Specifically, the trial focuses on the use of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumors. The study is currently in the recruiting phase and is expected to be completed by April 2026. The trial is open to both male and female participants aged 18 to 75 and focuses on pancreatic cancer, colorectal cancer, and lung adenocarcinoma cancer. Contact information for the primary and backup contacts for the trial is also provided. [Extracted from the article]

Immatics Us Inc. has been issued a patent for methods of manufacturing T cells for adoptive T cell therapy (ACT). The patent describes a method for preparing T cells by isolating CD8+ T cells from a blood sample, culturing them in the presence of cytokines, and then contacting them with a multimer containing a target peptide in complex with an MHC molecule. The contacted T cells are sorted and expanded for use in ACT. The patent claims also include the use of binding agents, protein kinase inhibitors, and a closed system for sorting and expanding the T cells. This patent provides a solution for the simple and cost-effective manufacturing of T cells for ACT. [Extracted from the article]

A recent study conducted at the Mayo Clinic in Rochester, Minnesota, examined the factors that contribute to severe cytopenia and therapy-related myeloid neoplasms (t-MN) in patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy for hematological malignancies. The study found that advanced age, anemia, and thrombocytopenia at the time of evaluation for CAR-T eligibility were associated with the development of post-treatment severe cytopenia and t-MN. The researchers recommend further multi-center studies to validate these findings. This information is valuable for patients and healthcare providers in making informed decisions about CAR-T therapy and stem cell collection. [Extracted from the article]

AstraZeneca has conducted research on the cryopreservation and banking of patients' leukapheresis materials for CAR-T cell therapies. The study aimed to determine the optimal temperature range for transferring cryopreserved materials from controlled rate freezers to ultracold storage without affecting CAR-T cell production and functionality. The findings showed that there is no significant influence on CAR-T cell expansion, differentiation, or in-vitro function when transferring materials at temperatures ranging from -30 degrees C to -80 degrees C. This research suggests that cryopreserved materials can be safely transferred at higher temperatures for autologous CAR-T cell therapies. [Extracted from the article]