Latest news with #CAR_T_cell_therapy
Associated Press
8 hours ago
- Business
- Associated Press
CARsgen Presents Research Results on Satri-cel in The Lancet and at the 2025 ASCO Annual Meeting
SHANGHAI, June 1, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: a company focused on developing innovative CAR T-cell therapies, announces that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ('satri-cel', CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO Annual Meeting. Further details have been posted on the corporate website The article in The Lancet was titled 'Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial'. Full article available at: The oral presentation at the 2025 ASCO Annual Meeting (Abstract 4003) was titled 'Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)'. Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of this study, said, 'The CT041-ST-01 trial represents the world's first randomized controlled clinical study of CAR-T cell therapy for solid tumors. In patients with heavily pretreated, advanced gastric/gastroesophageal junction cancer who have extremely limited treatment options and poor prognosis, satri-cel has demonstrated breakthrough efficacy with significant clinical benefits, including much improved progression-free survival (PFS), overall survival (OS), and tumor response rates. This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel's potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients' survival, and ultimately pursue potential cures.' Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, 'We are honored that the CT041-ST-01 study results were published in The Lancet—a premier, global medical journal—and presented at the 2025 ASCO Annual Meeting. The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy. These achievements are a testament to the whole research team's years of dedication, and we extend our deepest gratitude to patients and their families for their trust and participation. This year, satri-cel has been granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. We plan to submit a New Drug Application (NDA) for satri-cel to the NMPA this month and anticipate its approval as the world's first commercially available CAR-T product for solid tumors, bringing benefits to patients.' About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading 'Principal Risks and Uncertainties' in our most recent annual report and interim report and other announcements and reports made available on our corporate website, No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit View original content to download multimedia: SOURCE CARsgen Therapeutics
The Independent
a day ago
- Health
- The Independent
Innovative treatment effective in patients with certain tumours, study suggests
An innovative treatment that reprogrammes immune cells to recognise and kill cancer has been shown to be effective on patients with certain tumours in a pioneering trial. CAR T-cell therapy is usually used to treat some types of blood cancer. It involves genetically modifying a patient's T cells – a type of white blood cell – in a lab, before returning them to the bloodstream. A new first of its kind trial explored the use of the treatment in patients with advanced stomach cancer and gastroesophageal junction (GEJ) cancer, which develops at the point where the oesophagus meets the stomach. The phase two study, led by researchers in China, included people diagnosed with advanced stomach or GEJ cancer which had not responded to two previous lines of treatment. Some 104 patients were earmarked for CAR T-cell therapy while 52 were given standard care, which included a selection of drugs chosen by their doctor. Those who had CAR T-cell therapy lived an average for 7.9 months, compared to 5.5 months with standard care. Patients who received the treatment also spent 3.3 months without their cancer progressing compared to 1.8 months in the standard group. Researchers said that the study is the 'first randomised controlled trial of CAR T-cell therapy in solid tumours globally' and shows the treatment 'resulted in a significant improvement in progression-free survival, with a manageable safety profile'. They added that the findings, published in the Lancet and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, support CAR T-cell therapy 'as a new third-line treatment' for patients with advanced stomach and GEJ cancer.
Medscape
2 days ago
- Business
- Medscape
CAR T-Cell Therapy Boosts PFS in Advanced Gastric Cancer
In patients with advanced Claudin-18 isoform 2 (CLDN18.2) -positive gastric or gastroesophageal junction cancers, satricabtagene autoleucel (satri-cel) chimeric antigen receptor (CAR) T-cell therapy significantly extended progression-free survival (PFS) compared with treatment of physician's choice (TPC). METHODOLOGY CLDN18.2, a tight-junction protein, is overexpressed in patients with gastric and gastroesophageal junction (GEJ) cancers. Satri-cel, an autologous CLDN18.2-specific CAR T-cell therapy, showed promise in previously treated patients with advanced disease, but further validation is needed. The new phase 2 randomized controlled trial involved 156 patients with pathologically confirmed CLDN18.2-positive advanced gastric or GEJ cancer who were refractory to two or more previous lines of treatment. The study was conducted in multiple centers in China, and the median age of participants was 52 years. Participants were randomly assigned in a 2:1 ratio to receive either satri-cel (IV infusion, up to three times at 250 × 10 6 cells; n = 104) or TPC (n = 52) that included nivolumab, paclitaxel, docetaxel, irinotecan, or rivoceranib. cells; n = 104) or TPC (n = 52) that included nivolumab, paclitaxel, docetaxel, irinotecan, or rivoceranib. In the satri-cel group, 85% of patients received at least one infusion of satri-cel, 31% received a second infusion, and 6% received a third infusion. In the TPC group, 92% of patients received at least one dose of their treatment. The primary endpoint was PFS assessed by a blinded independent review committee. The key secondary endpoint was overall survival (OS). The median follow-up time for PFS was 9.07 months in the satri-cel group and 3.45 months in the TPC group. The median follow-up time for OS was 14.42 months and 11.33 months in the satri-cel and TPC groups, respectively. TAKEAWAY In the intention-to-treat population, the median PFS was 3.25 months in the satri-cel group and 1.77 months in the TPC group. Satri-cel reduced the risk for progression or death by 63% (hazard ratio [HR], 0.37; P < .0001). Median OS showed improvement with satri-cel vs TPC (7.92 vs 5.49 months), although it did not reach statistical significance (HR, 0.69; P = .0416). < .0001). Median OS showed improvement with satri-cel vs TPC (7.92 vs 5.49 months), although it did not reach statistical significance (HR, 0.69; = .0416). The objective response rate was notably higher in the satri-cel group than in the TPC group (22% vs 4%), with disease control rates of 63% and 25%, respectively. The median duration of response was 5.52 months in the satri-cel group. Only two patients in the TPC group showed a partial response, with durations of 4.47 months and 5.42 months, respectively. The median duration of disease control was 3.61 months and 4.27 months in the satri-cel and TPC groups, respectively. All patients in the satri-cel group experienced treatment-emergent adverse events compared with 92% in the TPC group. Grade 3 or higher adverse events occurred in 99% of patients in the satri-cel group and 63% of those in the TPC group; the most common ones were decreased lymphocyte count (99%), decreased white blood cell count (98%), and cytokine release syndrome (95%). IN PRACTICE In this randomized, phase 2 study, "satri-cel was associated with a statistically significant increase in progression-free survival and clinically meaningful increase in overall survival compared with TPC, along with a manageable safety profile in patients with previously treated, advanced, CLDN18.2-positive gastric or gastroesophageal junction cancer," the authors write. SOURCE The study, led by Changsong Qi, MD, Beijing Key Laboratory of Cell & Gene Therapy for Solid Tumour, State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Department of Early Drug Development Centre, Peking University Cancer Hospital & Institute in Beijing, China, was published online May 31 in The Lancet . LIMITATIONS The sample size — powered for PFS — might be insufficient to yield definitive conclusions from the subgroup analyses. Some patients in the satri-cel group could not receive CAR T-cell infusion after apheresis, making them ineligible for treatment. The time between apheresis and CAR T-cell infusion remains a significant limiting factor, particularly in the case of those experiencing rapid disease progression. DISCLOSURES The study was funded by CARsgen Therapeutics, the National Key Research and Development Program of China, the National Natural Science Foundation of China, Beijing Hospitals Authority Youth Programme, Science Foundation of Peking University Cancer Hospital, Clinical Medicine Plus X—Young Scholars Project of Peking University, and the Peking University Clinical Scientist Training Program. Five authors declared being employees of CARsgen Therapeutics. The other authors declared no competing interests.
National Post
3 days ago
- Business
- National Post
CAR T Vision Coalition Launches with Ambitious Goal to Double Patients Treated with the Curative Potential of CAR T-cell Therapy by 2030
Article content CHICAGO — Today an international coalition announces the launch of CAR T Vision to unite stakeholders around the shared ambition that every eligible patient should have the opportunity for cure with CAR T-cell therapy. By 2030, the aim is to double the proportion of eligible patients treated with CAR T-cell therapy. As outlined in the new roadmap report, the coalition will work to address access challenges and drive meaningful change in the CAR T-cell therapy healthcare ecosystem with a focus on three critical priorities: increasing awareness and understanding of CAR T-cell therapy; expanding resources and capacity to deliver CAR T-cell therapy; and developing sustainable and innovative financing approaches to manage the costs of treatment and care. Article content 'Despite CAR T-cell therapy being available in the United States for nearly seven years in large B-cell lymphoma, only approximately two out of 10 eligible patients with some advanced blood cancers ever receive CAR T-cell therapy,' said Miguel Perales, MD, Chief, Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer Center (MSK); Past President, American Society for Transplantation and Cellular Therapy (ASTCT); and Co-Chair, CAR T Vision Steering Committee. 'When it comes to treating these potentially deadly cancers, every minute counts. That is why we established CAR T Vision with recommendations for interventions that, when adopted and scaled, will help many more eligible patients get the opportunity for cure within the next five years.' Article content The roadmap report, developed by an independent Steering Committee comprised of leadership from top North American and European patient advocacy groups, medical society organizations, academic and community treatment centers, health technology assessment, policy, and other subject matter experts, provides the foundations for advocacy and action by local stakeholders to address the specific access challenges patients face in different geographies. Building on the report, expert Working Groups will be established to translate the Vision into concrete, measurable actions, including specific recommendations and a measurement framework to track progress. Article content 'Limited awareness of CAR T-cell therapy, low referrals, hospital capacity challenges, and funding and reimbursement are among the barriers that either prevent people from accessing CAR T-cell therapy altogether or cause delays that advance a patient's cancer beyond the point of treatment eligibility. In short, these barriers cost lives,' said Anna Sureda, MD, PhD, Clinical Hematologist, Professor and Cell Therapy Researcher; and Co-Chair, CAR T Vision Steering Committee. 'We call on every stakeholder and organization with the ability to help shape better patient outcomes—policymakers, health system leaders, payors, healthcare providers, patient advocates, and industry—to join the growing coalition of Vision endorsers and help ensure every eligible patient has the opportunity for cure with CAR T-cell therapy.' Article content Making CAR T Vision a reality will require the coming together of a complex ecosystem of partners, each with their own unique role to play. To learn more about CAR T Vision, review the roadmap report and join the coalition, visit Article content CAR T-cell therapy involves engineering a person's own immune cells to target and treat cancer and is currently approved for certain types of aggressive blood cancers, enabling some patients to remain cancer free for more than five years. 4,5,6,7 Article content The CAR T Vision is for every eligible patient to have the opportunity for cure with CAR T-cell therapy. By 2030, the aim is to double the proportion of eligible patients treated with CAR T-cell therapy. The CAR T Vision Steering Committee includes leadership from top North American and European patient advocacy groups, medical society organizations, academic and community treatment centers, health technology assessment, policy, and other subject matter experts. The new roadmap report details the challenges CAR T Vision aims to resolve through multidisciplinary collaboration and the urgent actions needed to make the Vision a reality. The report and initial activities of the CAR T Vision Steering Committee have been funded by Gilead Sciences and Kite, as the inaugural supporter of CAR T Vision. Report content has been reviewed by Gilead Sciences and Kite. However, the Steering Committee has editorial control of the CAR T Vision and its outputs, including the report. Dr. Perales has financial interests related to Gilead Sciences and Kite. To learn more about CAR T Vision, review the report and join the growing coalition of endorsers, visit Article content 2 Chuhara, D, Liao, L, et al. Real-world experience of CAR T-cell therapy in older patients with relapsed/refractory diffuse large B-cell lymphoma. Blood. 2023, September 21. Article content 3 Canales Albendea MÁ, Canonico PL, Cartron G, et al. Comparative analysis of CAR T-cell therapy access for DLBCL patients: associated challenges and solutions in the four largest EU countries. Front Med (Lausanne). 2023;10:1128295. Published 2023 May 30. doi:10.3389/fmed.2023.1128295 Article content 4 Abramson J, Palomba ML, Gordon LI, et al. Five-Year Survival of Patients (pts) from Transcend NHL 001 (TRANSCEND) Supports Curative Potential of Lisocabtagene Maraleucel (liso-cel) in Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL). Blood. 2024;144(1):3125. Article content 5 Neelapu SS, Jacobson CA, Ghobadi A, et al. Five-year follow-up of ZUMA-1 supports the curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma. Blood. 2023 May 11;141(19):2307-2315. doi: 10.1182/blood.2022018893. PMID: 36821768; PMCID: PMC10646788. Article content 6 Rives S, Maude S, Hiramatsu H et al. S112: TISAGENLECLEUCEL IN PEDIATRIC AND YOUNG ADULT PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL): FINAL ANALYSES FROM THE ELIANA STUDY. HemaSphere 6():p 13-14, June 2022. | DOI: 10.1097/ Article content Article content Article content Article content Article content Article content
Yahoo
7 days ago
- Health
- Yahoo
Liv Hospital and Istinye University Announce Groundbreaking Academic Collaboration with University of Pennsylvania's Perelman School of Medicine
ISTANBUL, May 26, 2025 (GLOBE NEWSWIRE) -- Liv Hospital and Istinye University have signed a comprehensive collaboration protocol with the University of Pennsylvania's Perelman School of Medicine to advance cutting-edge treatments, scientific research, and education programs. The agreement highlights innovative approaches such as CAR T-cell therapy and proton therapy, and paves the way for new horizons in healthcare—spanning clinical practices, second-opinion services, international training initiatives, and the establishment of state-of-the-art cell production New Frontiers in Medicine Under this collaboration, Liv Hospital and Istinye University will develop joint clinical programs focusing on advanced treatment methods—particularly CAR T-cell therapy and proton therapy—and facilitate broader patient access to these breakthrough treatments. Turkish healthcare professionals will benefit from scientific conferences featuring Perelman School of Medicine experts, while tailored training programs—both online and in person—will be offered to Liv Hospital and Istinye University physicians. Second-Opinion Service for Global Assurance For complex and advanced cases, Perelman School of Medicine experts will provide consultation and assessments to physicians at Liv Hospital and Istinye University, ensuring patients benefit from a global standard of care. This second-opinion program will give healthcare professionals a direct line to internationally renowned specialists, fostering collaborative insights and a broader perspective on diagnostic and treatment strategies. Strengthening Research Through Collaboration Beyond clinical applications and education, the partnership sets a robust framework for joint biomedical research. All projects will adhere to international scientific and ethical guidelines, driving knowledge creation, innovation, and progress toward the treatments of the future. A New Era in Cancer Care: Cell-Based Therapies According to Prof. Dr. Erdal Karaöz, Director of the Liv Hospital Regenerative Medicine and Stem Cell Center, 'Today, cellular therapy has become a centerpiece of groundbreaking cancer treatments. Our collaboration with the University of Pennsylvania—the birthplace of many revolutionary scientific developments in this field—is immensely significant. Liv Hospital will be among the first institutions in Turkey to implement cellular therapies, and through the international-standard laboratories we are establishing with Istinye University, we are preparing to produce these therapeutic cells in-house. 'Under the supervision of the Ministry of Health and in compliance with all scientific and ethical regulations, these laboratories will produce cell-based treatment products that will soon be used in Turkey—especially for certain hematologic cancers. This approach is not limited to oncology; it has the potential to evolve into a transformative treatment model for solid tumors and for ongoing clinical research in autoimmune disorders. In the future, diseases like type 1 diabetes, systemic lupus erythematosus, and multiple sclerosis (MS) may also be treated using this technology.' New Hope for Resistant Cancers: CAR T-Cell Therapy 'Harnessing the power of cellular therapies—particularly CAR T-cell therapy—offers renewed hope for patients with lymphoma, specific subtypes of leukemia, and multiple myeloma that are resistant to current treatments or have relapsed,' said Prof. Dr. Mehmet Hilmi Doğu, Hematology Specialist at Liv Hospital. 'We are working diligently to provide this advanced technology—often inaccessible in many parts of the world in collaboration with internationally recognized centers in this field. 'Moreover, CAR T-cell therapy extends beyond hematologic malignancies. It shows promise for autoimmune conditions and certain neurological disorders, and we believe it will soon become an indispensable pillar of modern medicine.' Strengthening a Global Vision Liv Hospital Group Coordinator and Istinye University Executive Board Member, Meri İstiroti, expressed enthusiasm about the partnership: 'We view scientific collaborations as more than just knowledge-sharing; they are transformative engagements that directly shape the future of healthcare. At Liv Hospital and Istinye University, we strive for a vision that not only addresses today's needs but anticipates tomorrow's challenges. Partnering with an institution as established and forward-thinking as the Perelman School of Medicine at the University of Pennsylvania will fortify our country's international standing in healthcare. 'This collaboration—encompassing clinical programs that increase access to advanced treatment methods and research projects that drive scientific innovation—aims to add value across all levels of healthcare. We believe it will offer inspiring opportunities for patients, students, and budding researchers, further enhancing our collective capacity to deliver world-class care.' About Liv Hospital Founded in 2013 in Istanbul, Türkiye, Liv Hospital (an abbreviation of 'Leading International Vision') is a premier healthcare network offering world-class, multidisciplinary medical services. As part of MLP Care, one of Türkiye's largest healthcare providers, Liv Hospital operates JCI-accredited facilities in Istanbul (Ulus and Vadistanbul), Ankara, Samsun, Gaziantep, and an international branch in Baku, Azerbaijan. Renowned for combining advanced medical technologies with personalized, patient-centered care, Liv Hospital provides comprehensive treatment across more than 50 specialties. It is especially distinguished in fields such as oncology, cardiovascular surgery, organ transplantation, robotic surgery, and regenerative medicine. With a strong focus on international health tourism, Liv Hospital welcomes thousands of patients from over 80 countries each year. Its multilingual International Patient Center delivers full-service assistance, including medical second opinions, treatment coordination, visa and travel arrangements, interpreting services, and post-treatment follow-up—ensuring a seamless experience from arrival through recovery. Liv Hospital is committed to clinical excellence, continuous innovation, and compassionate care, making it one of the most trusted healthcare destinations in the region. Website: Media Contact:FL PR and Communicationsasset@ A photo accompanying this announcement is available at
