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Cellares and Mitsui Fudosan Launch Japan's First Automated CAR-T Manufacturing Facility

CAR-T
  • Cellares and Mitsui Fudosan are establishing Japan's first next-generation commercial production site for CAR-T cell therapies in Kashiwa City, utilizing automated manufacturing technology.
  • The facility will employ Cellares' Cell Shuttle™ and Cell Q™ platforms to reduce batch prices by up to 50% and eliminate manufacturing bottlenecks faced by conventional manual processes.
  • The Smart Factory is expected to provide employment to 350 people while addressing urgent patient needs for cell therapies in Japan and neighboring regions.
  • Local manufacturing will simplify cold chain logistics, accelerate vein-to-vein time, and reduce costs for pharmaceutical clients supplying the Japanese market.

Estrella Immunopharma Advances EB103 ARTEMIS T-Cell Therapy to Second Cohort in STARLIGHT-1 Trial for Advanced B-Cell Lymphomas

CAR-T
  • Estrella Immunopharma has dosed the first patient in the second cohort of its Phase I/II STARLIGHT-1 trial, evaluating EB103 at higher doses for advanced B-cell non-Hodgkin's lymphomas.
  • The first cohort demonstrated a favorable safety profile with no dose-limiting toxicities or treatment-related serious adverse events, along with a complete response.
  • EB103 utilizes ARTEMIS technology to potentially address limitations of traditional CAR-T therapies, including expanded access to high-risk patients with HIV-associated and CNS lymphomas.
  • The therapy targets CD19-positive cancer cells using a mechanism that more closely resembles endogenous T-cell receptor activation compared to conventional CAR-T approaches.

T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

NCT06343311RecruitingPhase 1
Estrella Biopharma, Inc.
Posted 6/1/2024

Sarvodaya Hospital Becomes First in India to Offer Terbium-161 PSMA Therapy for Advanced Prostate Cancer

CAR-T
  • Sarvodaya Hospital in Faridabad has become India's first theranostics and nuclear medicine center to introduce Terbium-161 PSMA therapy for metastatic castration-resistant prostate cancer.
  • The hospital has simultaneously launched CAR-T cell therapy for blood cancers including leukemia, lymphoma, and multiple myeloma, creating comprehensive cancer care under one roof.
  • This targeted therapy represents a significant advancement in precision oncology, delivering radiation directly to cancer cells while sparing healthy tissue.
  • The dual launch positions Sarvodaya as one of the few institutions in India offering end-to-end cancer care from diagnosis to the most advanced treatment options.

Medable Launches Digital Platform to Address 20% Dropout Rate in Cell and Gene Therapy Long-Term Follow-Up Studies

CAR-T
  • Medable unveiled a digital-first Long-Term Follow-Up model to address the 20% dropout rate in CAR T-cell therapy patients during FDA-required 15-year monitoring periods.
  • The platform offers remote and hybrid patient interactions to reduce travel burden and improve retention in cell and gene therapy trials using technologies like CRISPR-Cas9.
  • Traditional follow-up models face significant challenges with 80% of dropouts occurring at or after five years post-treatment due to distance, travel burden, and lack of awareness about local options.
  • The new model integrates seamless transition from parent trials, patient-first data capture, and personalized communication to maintain scientific rigor while reducing costs for sponsors and sites.

St George's Hospital Achieves Majority Remission Rate in First CAR-T Cell Therapy Patients

CAR-T
  • Seven patients at St George's Hospital in South West London have received CAR-T cell therapy, with the majority now in remission from blood cancers including lymphoma.
  • The treatment involves collecting a patient's T cells, genetically modifying them to target cancer cells, and reinfusing them as a one-time therapy for relapsed blood cancers.
  • Patients have returned to normal activities including travel and work, demonstrating the therapy's potential to restore quality of life beyond clinical outcomes.
  • The hospital underwent stringent approval processes and established specialized teams to deliver this complex immunotherapy requiring intensive care support capabilities.

Community Oncology Practices Expand Access to CAR-T and Bispecific Therapies as Workforce Challenges Persist

CAR-TPrecision Medicine
  • Advanced cancer therapies including CAR-T and bispecific treatments are increasingly being delivered in community settings, reducing patient travel burdens from months to shorter timeframes.
  • Community oncology practices, which deliver the majority of cancer care in the US, face significant workforce shortages exacerbated by the COVID-19 pandemic affecting oncologists, nurses, and support staff.
  • Long-term strategies to strengthen community oncology include expanding fellowship training in community settings, incentivizing rural placements, and developing specialized programs for advanced practice providers.
  • Small community practices with 2-3 clinicians face ongoing challenges with reimbursement pressures and the high costs of implementing new technologies and therapies.

Scientists Develop In Vivo CAR T-Cell Engineering to Reduce Cancer Treatment Costs and Complexity

CAR-T
  • Researchers at the University of Pennsylvania have successfully created CAR T-cell therapy directly inside the bodies of mice and monkeys, eliminating the need for expensive laboratory manufacturing processes.
  • The new approach uses RNA-loaded fatty capsules that temporarily reprogram T-cells in vivo, achieving complete tumor elimination in mice and clearing all B-cells in primates within one day.
  • Traditional CAR T-cell therapy costs upwards of $500,000 per patient and requires weeks of manufacturing time, while this in vivo method could significantly reduce both costs and treatment delays.
  • Clinical trials in healthy humans have already begun, with the first patient dosed in recent weeks, though the temporary nature of the treatment may require repeated injections if cancer returns.

Vancouver General Hospital Launches Canada's First Dedicated Inpatient Clinical Trials Unit for Blood Cancer Therapies

CAR-T
  • Vancouver Coastal Health has launched British Columbia's first dedicated inpatient clinical trials unit for early-phase blood cancer therapies at Vancouver General Hospital.
  • The Hematology Research Unit will deliver revolutionary treatments including CAR T-cell therapy and first-in-human immunotherapies to patients with relapsed or treatment-resistant hematological diseases.
  • The $5 million facility features three private inpatient rooms and is fully integrated with the renowned Leukemia/Bone Marrow Transplant Program of BC.
  • The unit enables patients to access cutting-edge therapies without leaving the province while reducing costs to the provincial healthcare system through industry-funded care.

DLL3-Targeted Therapies Show Promise for Refractory Small Cell Lung Cancer Despite Clinical Challenges

CAR-TDrug Approval
  • Delta-like ligand 3 (DLL3) emerges as a critical therapeutic target in small cell lung cancer, with expression in 70-80% of SCLC cases and minimal presence in normal tissues.
  • Tarlatamab, the first FDA-approved DLL3-targeting bispecific T-cell engager, demonstrates clinical efficacy in extensive-stage SCLC patients who progressed after chemotherapy.
  • Multiple DLL3-targeted approaches including antibody-drug conjugates, CAR-T cells, and trispecific antibodies are advancing through clinical trials despite early setbacks with rovalpituzumab tesirine.
  • Clinical challenges persist including cytokine release syndrome, tumor heterogeneity, and the need for biomarker-guided patient selection strategies.

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

NCT04885998CompletedPhase 1
Amgen
Posted 9/27/2021

Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

NCT06502977Active, Not RecruitingPhase 2
Amgen
Posted 8/27/2024

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

NCT06117774RecruitingPhase 3
Amgen
Posted 2/20/2024

Study of DLL3-CAR-NK Cells in the Treatment of Extensive Stage Small Cell Lung Cancer

NCT05507593Unknown StatusPhase 1
Tianjin Medical University Cancer Institute and Hospital
Posted 9/1/2022

Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)

NCT03043872Active, Not RecruitingPhase 3
AstraZeneca
Posted 3/27/2017

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

NCT02763579CompletedPhase 3
Hoffmann-La Roche
Posted 6/7/2016

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT05361395RecruitingPhase 1
Amgen
Posted 8/24/2022

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

NCT04471727RecruitingPhase 1
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Posted 12/14/2020

A Study of Hospital-at-Home for People Receiving Tarlatamab

NCT06957314RecruitingNot Applicable
Memorial Sloan Kettering Cancer Center
Posted 4/23/2025

Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer

NCT01901653CompletedPhase 1
Stemcentrx
Posted 7/1/2013

A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

2023-506541-39-00Active, Not RecruitingPhase 1
Amgen Inc.
Posted 12/26/2017

A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

NCT04429087RecruitingPhase 1
Boehringer Ingelheim
Posted 7/29/2020

Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer

NCT02674568CompletedPhase 2
AbbVie
Posted 1/25/2016

Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

NCT03061812CompletedPhase 3
AbbVie
Posted 4/11/2017

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

NCT03033511TerminatedPhase 3
AbbVie
Posted 2/7/2017

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of RO7616789 in Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

NCT05619744CompletedPhase 1
Hoffmann-La Roche
Posted 1/23/2023

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

NCT05740566Active, Not RecruitingPhase 3
Amgen
Posted 5/31/2023

PET/CT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56

NCT04199741RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 12/11/2019

A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC

NCT03392064SuspendedPhase 1
Amgen
Posted 9/10/2018

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT05060016Active, Not RecruitingPhase 2
Amgen
Posted 12/1/2021

Dual-Target CAR-T Therapy Shows Promise for Glioblastoma with 24.5-Month Median Survival

CAR-T
  • A clinical trial combining PSMA and GD2 CAR-T cells achieved a median overall survival of 24.5 months in six patients with refractory or relapsed gliomas, significantly exceeding typical survival rates of 5-7 months.
  • All patients achieved clinical benefit with 50% complete response rate, while treatment was well-tolerated with manageable side effects including grade 1 cytokine release syndrome in half of patients.
  • Mathematical modeling studies suggest that lower CAR-T doses administered at longer intervals may optimize treatment effectiveness by maintaining sustained immune responses without depleting therapeutic cells.
  • Patients with lower tumor burden demonstrated superior outcomes, with 100% two-year survival compared to zero survival in high tumor burden cases, highlighting the importance of early intervention.

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