MedPath

Tagged News

AGC Biologics Expands Global Cell Therapy Network with New Yokohama Facility and Advanced Single-Use Bioreactor Technology

CAR-T
  • AGC Biologics is launching cell therapy development and clinical manufacturing services at its Yokohama Technical Center on July 1, 2025, expanding its global cell therapy operations to three continents.
  • The company is introducing two 5,000 L Thermo Scientific DynaDrive Single-Use Bioreactors at its new Yokohama manufacturing facility, making it one of the most advanced sites in Japan for large-scale biologics production.
  • The new facility will support mammalian-based protein biologics, cell therapies, and messenger RNA production, with GMP operations scheduled to begin in 2027.
  • AGC Biologics maintains the second largest global network of single-use manufacturing capacity by volume in the industry, according to bioTRAK data.

CRISPR Gene Editing Advances from Laboratory to Clinic with 250+ Active Trials Across Multiple Therapeutic Areas

Gene EditingCAR-TDrug Approval
  • CRISPR Medicine News tracks approximately 250 clinical trials involving gene-editing therapeutic candidates as of February 2025, with more than 150 trials currently active across diverse therapeutic areas.
  • CASGEVY became the first approved CRISPR-based therapy in 2023, receiving regulatory clearance in multiple regions for treating sickle cell disease and beta thalassemia through foetal haemoglobin induction.
  • Gene editing for blood disorders continues to lead the clinical landscape, with the majority of Phase 3 trials targeting sickle cell disease and beta thalassemia, while Phase 3 trials are also underway in hereditary amyloidosis and immunodeficiencies.
  • Clinical applications now span 15+ therapeutic areas including blood cancers, viral diseases, metabolic disorders, autoimmune diseases, inherited eye diseases, cardiovascular disease, and neurological conditions.

Hong Kong Achieves First Myeloma CAR-T Treatment Using Mainland-Manufactured Therapy

CAR-T
  • HKUMed and Queen Mary Hospital successfully treated the first myeloma patient in Hong Kong with CAR-T cell therapy, achieving a very good response without severe complications.
  • The treatment marks the first use of advanced CAR-T cellular therapy manufactured in mainland China in Hong Kong, opening new possibilities for cross-border therapeutic collaboration.
  • The BCMA-targeting CAR-T therapy provides a life-saving option for myeloma patients who have relapsed or failed to respond to standard treatments including stem cell transplantation.
  • Queen Mary Hospital remains the only facility in Hong Kong offering CAR-T immunotherapy for myeloma, with plans to treat five to ten patients annually through their pilot program.

Targeted Therapies and Immunotherapy Advances in Non-Small Cell Lung Cancer: A Comprehensive Review

Targeted TherapyCAR-TOncologyPrecision Medicine
  • Targeted therapies for NSCLC have revolutionized treatment for patients with specific genetic alterations, with EGFR, ALK, and ROS1 inhibitors showing significant improvements in progression-free survival compared to traditional chemotherapy.
  • Immunotherapy, particularly immune checkpoint inhibitors targeting PD-1/PD-L1 and CTLA-4, has become a cornerstone in NSCLC treatment, with newer targets like LAG-3, TIM-3, and TIGIT showing promise in ongoing clinical trials.
  • Advanced cellular therapies including adoptive cell transfer, CAR-T cells, and cancer vaccines represent the next frontier in NSCLC treatment, particularly for patients with "cold tumors" who don't respond to standard immunotherapies.

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614CompletedPhase 3
Regeneron Pharmaceuticals
Posted 3/6/2018

Avelumab in First-line NSCLC (JAVELIN Lung 100)

NCT02576574CompletedPhase 3
EMD Serono Research & Development Institute, Inc.
Posted 10/29/2015

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

NCT01642004CompletedPhase 3
Bristol-Myers Squibb
Posted 10/16/2012

A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

NCT04623775Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 2/17/2021

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

NCT03849469CompletedPhase 1
Xencor, Inc.
Posted 5/29/2019

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer

NCT01583686TerminatedPhase 1
National Cancer Institute (NCI)
Posted 5/4/2012

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

NCT01903993CompletedPhase 2
Hoffmann-La Roche
Posted 8/6/2013

Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer Patients

NCT02879760CompletedPhase 1
Turnstone Biologics, Corp.
Posted 3/8/2017

A Trial of AK104 Plus Anlotinib in NSCLC

NCT04646330CompletedPhase 1
Akeso
Posted 11/18/2020

A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

NCT02349724Unknown StatusPhase 1
Southwest Hospital, China
Posted 12/1/2014

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT02366143CompletedPhase 3
Hoffmann-La Roche
Posted 3/31/2015

A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

NCT03652077CompletedPhase 1
Incyte Corporation
Posted 9/24/2018

Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

NCT02608268TerminatedPhase 1
Novartis Pharmaceuticals
Posted 11/23/2015

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

NCT01524978CompletedPhase 2
Hoffmann-La Roche
Posted 4/12/2012

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

NCT01970865CompletedPhase 1
Pfizer
Posted 1/8/2014

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

NCT03625323CompletedPhase 2
Immutep S.A.S.
Posted 2/18/2019

PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies

NCT03365791CompletedPhase 2
Novartis Pharmaceuticals
Posted 1/24/2018

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

NCT03219268CompletedPhase 1
MacroGenics
Posted 8/18/2017

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

NCT01774721CompletedPhase 3
Pfizer
Posted 5/9/2013

Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

NCT02475213CompletedPhase 1
MacroGenics
Posted 7/1/2015

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

NCT00585195CompletedPhase 1
Pfizer
Posted 4/19/2006

Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer

NCT04348643Unknown StatusPhase 1
Chongqing Precision Biotech Co., Ltd
Posted 2/20/2020

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

NCT02737501CompletedPhase 3
Ariad Pharmaceuticals
Posted 5/26/2016

A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer

NCT04931654Active, Not RecruitingPhase 1
AstraZeneca
Posted 9/28/2021

Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

NCT03709706TerminatedPhase 1
GlaxoSmithKline
Posted 12/31/2018

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

NCT02477826CompletedPhase 3
Bristol-Myers Squibb
Posted 8/5/2015

A Trial of ChAdOx1 and MVA Vaccines Against MAGE-A3 and NY-ESO-1

NCT04908111SuspendedPhase 1
Cancer Research UK
Posted 10/15/2021

Biological Therapy in Treating Patients With Metastatic Cancer

NCT00004604CompletedPhase 1
Duke University
Posted 2/1/1997

CTLA-4 and PD-1 Antibodies Expressing EGFR-CAR-T Cells for EGFR Positive Advanced Solid Tumor

NCT03182816Unknown StatusPhase 1
Shanghai Cell Therapy Research Institute
Posted 6/7/2017

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03563716Active, Not RecruitingPhase 2
Genentech, Inc.
Posted 8/10/2018

Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

NCT00923312CompletedPhase 1
CureVac
Posted 5/1/2009

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018

Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors

NCT03689192CompletedPhase 1
Herlev Hospital
Posted 12/17/2018

Phase I/II Study of Anti-Mucin1 (MUC1) CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor

NCT02587689Unknown StatusPhase 1
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Posted 10/1/2015

Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001)

NCT02964013CompletedPhase 1
Merck Sharp & Dohme LLC
Posted 12/13/2016

Trial of RNActive®-Derived Cancer Vaccine and Local Radiation in in Stage IV Non Small Cell Lung Cancer (NSCLC)

NCT01915524TerminatedPhase 1
CureVac
Posted 4/1/2013

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

NCT05834348Completed
Pfizer
Posted 6/23/2023

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

NCT00446225CompletedPhase 3
Spanish Lung Cancer Group
Posted 2/15/2007

MGC018 With or Without MGA012 in Advanced Solid Tumors

NCT03729596TerminatedPhase 1
MacroGenics
Posted 11/21/2018

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

NCT03525782Unknown StatusPhase 1
The First Affiliated Hospital of Guangdong Pharmaceutical University
Posted 2/1/2018

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

NCT01203917CompletedPhase 4
AstraZeneca
Posted 9/1/2010

A Study of RNA Tumor Vaccine in Patients With Advanced Solid Tumors

NCT05202561Unknown StatusPhase 1
First Affiliated Hospital Bengbu Medical College
Posted 3/10/2022

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC

NCT03970746Active, Not RecruitingPhase 1
PDC*line Pharma SAS
Posted 9/10/2019

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer

NCT04117087Active, Not RecruitingPhase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Posted 5/28/2020

Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies

NCT02706392TerminatedPhase 1
Fred Hutchinson Cancer Center
Posted 3/16/2016

Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)

NCT01295827CompletedPhase 1
Merck Sharp & Dohme LLC
Posted 3/4/2011

A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors

NCT03708328CompletedPhase 1
Hoffmann-La Roche
Posted 10/15/2018

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

NCT03470922Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 4/11/2018

Evaluation of SAR408701 in Patients With Advanced Solid Tumors

NCT02187848TerminatedPhase 1
Sanofi
Posted 7/23/2014

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

NCT03562871CompletedPhase 1
IO Biotech
Posted 8/22/2018

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

NCT00949650CompletedPhase 3
Boehringer Ingelheim
Posted 8/14/2009

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

NCT01336634CompletedPhase 2
Novartis Pharmaceuticals
Posted 8/5/2011

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

NCT01121393CompletedPhase 3
Boehringer Ingelheim
Posted 4/19/2010

Efficacy Study of Vx001 Vaccine in NSCLC Patients

NCT01935154CompletedPhase 2
Vaxon Biotech
Posted 8/1/2012

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

NCT05239143Active, Not RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 2/15/2022

PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer

NCT04539977RecruitingPhase 2
Shanghai Pulmonary Hospital, Shanghai, China
Posted 9/1/2020

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02296125Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/3/2014

Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

NCT02414269Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 5/1/2015

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

NCT02075840CompletedPhase 3
Hoffmann-La Roche
Posted 8/19/2014

Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer

NCT02381314CompletedPhase 1
MacroGenics
Posted 3/26/2015

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

NCT04140500Active, Not RecruitingPhase 1
Hoffmann-La Roche
Posted 11/11/2019

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

NCT00932893CompletedPhase 3
Pfizer
Posted 9/1/2009

Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC

NCT05060796RecruitingEarly Phase 1
Second Affiliated Hospital of Guangzhou Medical University
Posted 9/1/2019

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

NCT02125461CompletedPhase 3
AstraZeneca
Posted 5/7/2014

Immunotherapy Advances Show Promise for Pediatric Osteosarcoma Treatment

CAR-TMonoclonal Antibody
  • Pediatric osteosarcoma remains a challenging malignancy with poor prognosis despite treatment advances, with pulmonary metastasis occurring in over 85% of metastatic cases.
  • The tumor microenvironment plays a crucial role in disease progression, with tumor-associated macrophages and T cells being predominant immune infiltrates that influence patient outcomes.
  • Emerging immunotherapies including mifamurtide, CAR-T cell therapy, and immune checkpoint inhibitors demonstrate therapeutic potential, though overcoming immunosuppressive factors remains essential.
  • Novel prognostic biomarkers within the immune microenvironment, including immune-related gene signatures and inflammatory markers, could guide individualized treatment strategies.

A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric Antigen Receptor in Children and Young Adults With GD2+ Solid Tumors

NCT02107963CompletedPhase 1
National Cancer Institute (NCI)
Posted 2/28/2014

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas

NCT02301039CompletedPhase 2
Sarcoma Alliance for Research through Collaboration
Posted 3/1/2015

Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

NCT00902044Active, Not RecruitingPhase 1
Baylor College of Medicine
Posted 2/11/2010

PeproMene Bio Secures $11 Million Investment to Advance BAFF-R CAR T-Cell Therapy for Follicular Lymphoma

CAR-TOncology
  • PeproMene Bio has received an $11 million investment from the Institute for Follicular Lymphoma Innovation to develop PMB-CT01, a novel BAFF-R CAR T-cell therapy for relapsed/refractory follicular lymphoma.
  • Early clinical results show promising efficacy with a 100% complete response rate in six non-Hodgkin lymphoma patients and minimal side effects, including in patients who relapsed after CD19 CAR T-cell therapy.
  • PMB-CT01 targets the BAFF-R receptor, which is crucial for B-cell survival, potentially making it difficult for tumor cells to escape therapy through antigen loss, a common limitation of current CD19-targeted therapies.

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

CAR T-Cell Therapy Emerges as Promising Treatment for Systemic Lupus Erythematosus

CAR-T
  • CAR T-cell therapy has shown remarkable efficacy in treating refractory systemic lupus erythematosus (SLE), with clinical trials demonstrating complete remission and drug-free periods in patients who failed multiple conventional treatments.
  • Both CD19-specific and dual CD19/BCMA-targeting CAR T-cells effectively eliminate autoreactive B cells and plasma cells, leading to normalization of complement factors, reduction in anti-dsDNA antibodies, and significant improvement in disease activity scores.
  • Despite promising results, challenges remain including optimal dosing, potential toxicities, and the need for refined targeting mechanisms, with future directions focusing on combination therapies, multi-specific targeting, and universal "off-the-shelf" CAR T-cell approaches.

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

NCT05624749RecruitingPhase 3
Novartis Pharmaceuticals
Posted 4/21/2023

IASO Bio's CAR-T Therapy Shows Sustained Efficacy in Multiple Myeloma Patients with Renal Impairment

CAR-T
  • IASO Bio's Equecabtagene Autoleucel (Eque-cel) demonstrated equivalent efficacy and safety in relapsed/refractory multiple myeloma patients with renal impairment compared to those without kidney dysfunction.
  • The FUMANBA-1 phase 2 study showed that CAR-T cell persistence is crucial for optimal disease control, with an efficacy-to-target ratio serving as a potential biomarker for treatment planning.
  • Among 107 patients treated with Eque-cel, those with higher efficacy-to-target ratios had significantly better progression-free survival and time to progression outcomes.
  • The therapy achieved a 97.8% MRD negativity rate with sustained remission at 12 months, while maintaining a favorable safety profile with minimal long-term hematological toxicity.

AbelZeta's Novel Bispecific CAR-T Therapy Shows Promise for Autoimmune Diseases in Preclinical Studies

CAR-T
• AbelZeta Pharma presented preclinical data for C-CAR168, a novel bispecific CAR-T therapy targeting both CD20 and BCMA for treatment-resistant lupus nephritis and SLE at ACR Convergence 2024.
• The dual-targeting approach showed effective elimination of pathogenic B cells and long-lived plasma cells in preclinical models, with minimal off-target toxicity and a favorable safety profile.
• FDA granted IND clearance for Phase 1 clinical development in May 2024, with early positive signals observed in an investigator-initiated trial in China treating refractory lupus nephritis patients.

IASO Bio Secures FDA Approval for BCMA CAR-T Therapy in Multiple Autoimmune Diseases

CAR-TDrug Approval
  • IASO Bio received FDA IND approval for Equecabtagene Autoleucel (Eque-cel) to treat multiple sclerosis, marking the second autoimmune indication approved in 2024.
  • The fully human anti-BCMA CAR-T therapy has now secured five total IND approvals across China and the US for various autoimmune diseases including lupus and myasthenia gravis.
  • Multiple sclerosis affects approximately 3.07 million patients worldwide with 400,000 in the US, representing a significant unmet medical need in neuroinflammatory diseases.
  • The therapy targets BCMA-expressing B cells and plasma cells to reduce pathogenic autoantibodies and suppress autoimmune inflammation across multiple disease indications.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.