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Extracellular Vesicles Emerge as Dual Players in Cancer Immunotherapy Resistance and Treatment Innovation

CAR-T
  • Extracellular vesicles (EVs) play a complex dual role in cancer immunotherapy, both facilitating resistance mechanisms and offering innovative therapeutic opportunities for treatment enhancement.
  • Cancer cells exploit EVs to transfer drug-resistant proteins and immunosuppressive molecules like TGF-β and PD-L1, creating an immunosuppressive tumor microenvironment that undermines immune checkpoint inhibitors and CAR-T cell therapies.
  • Engineered EVs show promising potential as next-generation cancer vaccines and drug delivery platforms, with CAR-T cell-derived EVs demonstrating superior tumor penetration and reduced side effects compared to traditional cell-based therapies.
  • Despite therapeutic promise, clinical translation faces significant challenges including large-scale production, standardized purification methods, and long-term storage stability that must be addressed for widespread clinical application.

iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation

NCT03608631Active, Not RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 1/27/2021

Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion

NCT01854866Unknown StatusPhase 2
Huazhong University of Science and Technology
Posted 5/1/2013

Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

NCT02657460Unknown StatusPhase 2
Wuhan Union Hospital, China
Posted 1/1/2016

Waters Acquires Halo Labs to Enhance Biologic Therapy Analysis Capabilities

CAR-T
  • Waters Corporation has acquired Halo Labs, gaining specialized imaging technology that detects particles in cell, protein, and gene therapies with capabilities beyond standard methods.
  • The Aura platform's subvisible particle technology provides critical insights for CAR T-cell therapies by detecting translucent process impurities that conventional methods miss.
  • This strategic acquisition strengthens Waters' position in specialized analytical technologies for emerging biopharmaceuticals, particularly supporting quality control in advanced therapy development.

Poolbeg Pharma Secures £4.1 Million Fundraising to Advance Clinical Programs in Oncology and Obesity

OncologyAICAR-T
  • Poolbeg Pharma has announced a £4.1 million conditional fundraising to advance its POLB 001 Phase 2a trial for cancer immunotherapy-induced Cytokine Release Syndrome and oral GLP-1 proof of concept trial for obesity.
  • The fundraising comprises a £2.655 million placing, £1.345 million in direct subscriptions, and up to £100,000 from a retail offer, with shares issued at 2.5 pence each, representing a 12% discount to the previous closing price.
  • The proceeds will extend Poolbeg's cash runway into 2027, supporting multiple near-term clinical data catalysts including first patient dosing for POLB 001 in H2 2025 and topline data expected in H2 2026.

Aging Impairs CAR-T Cell Therapy Effectiveness Through Metabolic Decline, Swiss Study Reveals

CAR-TOncology
  • New research from Swiss institutions demonstrates that age-related immune decline significantly reduces the effectiveness of CAR-T cell cancer therapy by impairing mitochondrial function and metabolism.
  • Scientists identified decreased levels of nicotinamide adenine dinucleotide (NAD) as the key factor behind reduced antitumor activity in CAR-T cells from older individuals.
  • Researchers successfully rejuvenated aged CAR-T cells by restoring NAD levels in preclinical models, suggesting potential strategies to improve immunotherapy outcomes in older cancer patients.

Lymphodepletion Enhances MAR-T Cell Therapy Efficacy in Lymphoma Patients, Marker Therapeutics Reports

OncologyCAR-T
  • Marker Therapeutics' Phase 1 APOLLO study shows lymphodepletion significantly improves expansion and persistence of MT-601 MAR-T cells in lymphoma patients, potentially enhancing anti-tumor activity.
  • Early clinical data reveals promising efficacy with 78% objective response rate and 44.4% complete response rate in patients who relapsed after or are not candidates for anti-CD19 CAR-T therapy.
  • The non-genetically modified MAR-T cell approach targets six different tumor antigens, demonstrating excellent safety with no dose-limiting toxicities while potentially offering manufacturing advantages over current engineered T cell therapies.

Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma

NCT05798897RecruitingPhase 1
Marker Therapeutics, Inc.
Posted 1/2/2023

Novel BAFF-R CAR-T Therapy Achieves Complete Response in Heavily Pretreated Follicular Lymphoma Patient

CAR-TOncology
  • PeproMene Bio's first-in-class BAFF-R targeted CAR-T cell therapy (PMB-CT01) has achieved complete remission in a heavily pretreated follicular lymphoma patient who had failed seven prior therapies including CD19 CAR-T.
  • All seven patients with relapsed/refractory B-cell non-Hodgkin lymphoma treated with PMB-CT01 have achieved complete responses lasting from 1 to 29+ months, with minimal toxicity reported.
  • PMB-CT01 targets the BAFF receptor, which is crucial for B-cell survival, potentially making it harder for tumor cells to escape therapy through antigen loss compared to CD19-targeted approaches.

BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-NHL

NCT05370430RecruitingPhase 1
PeproMene Bio, Inc.
Posted 6/13/2022

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL

NCT04690595RecruitingPhase 1
PeproMene Bio, Inc.
Posted 5/18/2021

Stem Cell Transplant Maintains Cost-Effective Role Despite Novel Multiple Myeloma Therapies

CAR-T
  • Stem cell transplantation remains a cornerstone treatment for multiple myeloma despite the emergence of CAR T-cell therapy and bispecific antibodies, offering a cost-effective "one and done" approach that has proven efficacy over four decades.
  • Novel therapies like CAR T and bispecifics face adoption challenges including hospitalization requirements, cytokine release syndrome management, and significantly higher costs, with CAR T therapy costing up to half a million dollars.
  • Experts emphasize that these therapies should complement rather than compete with each other, as multiple myeloma remains incurable and requires sequential treatment approaches to maximize overall survival.
  • The widespread adoption of bispecific therapies is limited by REMS requirements and the need for inpatient step-up dosing due to cytokine release syndrome risks, particularly affecting rural and community settings.

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

NCT05257083RecruitingPhase 3
Stichting European Myeloma Network
Posted 10/10/2023

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

NCT04923893Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/19/2021

Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

NCT05396885Active, Not RecruitingPhase 2
Kite, A Gilead Company
Posted 8/9/2022

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

NCT05652335RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/22/2022

Tessera Therapeutics Reports Breakthrough Gene Editing Results for Multiple Genetic Diseases

Rare DiseaseGene EditingCAR-T
  • Tessera's RNA Gene Writer technology achieved 76% and 70% editing efficiency in hepatocytes for alpha-1 antitrypsin deficiency and phenylketonuria respectively, with high specificity and durability in non-human primate studies.
  • Preclinical data for sickle cell disease demonstrated greater than 20% editing in long-term hematopoietic stem cells across multiple species, potentially reaching curative thresholds without requiring stem cell transplantation.
  • The company's proprietary lipid nanoparticle delivery system showed high liver specificity with no off-target activity detected, advancing the potential for in vivo gene editing therapies for multiple genetic disorders.

AbelZeta's C-CAR168 Shows Promising Results in Treating Refractory Lupus Nephritis and Multiple Sclerosis

CAR-T
  • Novel bispecific CAR-T therapy C-CAR168 targeting CD20/BCMA demonstrated positive safety profile with only low-grade cytokine release syndrome in early clinical trials for autoimmune diseases.
  • Among four lupus nephritis patients reaching 6-month evaluation, all achieved SRI(4) response with two complete remissions, allowing discontinuation of immunosuppressants and steroids in most patients.
  • Early efficacy signals were observed in a Secondary Progressive Multiple Sclerosis patient, including improved gait, reduced brain inflammation, and better functional assessment scores.

A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

NCT06249438RecruitingPhase 1
RenJi Hospital
Posted 3/20/2024

Intermountain Health Pioneers First Remote CAR-T Cell Collection Site in Southern Utah

CAR-TOncology
  • Intermountain Health has established the nation's first remote CAR-T cell collection site at St. George Regional Hospital, bringing advanced cancer treatment closer to patients in Southern Utah and Nevada.
  • The innovative satellite clinic eliminates the need for patients to travel hundreds of miles to Salt Lake City for initial collection procedures, significantly improving accessibility to this cutting-edge immunotherapy.
  • CAR-T cell therapy, which reprograms patients' immune cells to target and destroy cancer cells, has shown remarkable success in treating various hematologic cancers including leukemia, lymphoma, and multiple myeloma.

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