Infusion of T cells targeting BKV resulted in rapid responses, with 67.7% of patients seeing a complete or partial improvement in symptoms after 14 days. This increased to 81.6% of patients after 28 days post-infusion. No cases of grade 3 or grade 4 graft versus host disease (GVHD) or other infusion-related toxicities occurred.
Addressing a painful complication caused by BKV
BKV-associated hemorrhagic cystitis is an incredibly painful condition that causes significant morbidity in patients and can lead to worse cancer outcomes in the long term. Unfortunately, there are no effective treatments available. We were driven to develop this therapy to provide a better option for these patients, and this has emerged as a safe and effective therapy for patients at MD Anderson based on these results.
Katy Rezvani, M.D., Ph.D., Corresponding Author, Professor of Stem Cell Transplantation and Cellular Therapy
BKV is a human polyomavirus acquired by most people in early youth, Rezvani explained. Held in check by the immune system, BKV typically stays dormant in the cells lining the urinary tract, including the kidney, liver, bladder and ureters.
Allogeneic stem cell transplants, where stem cells come from a matched donor, require patients to be given therapies to suppress the immune system and protect against rejection. However, this can also trigger the BKV to start reproducing and cause severe cystitis, which could lead to hospitalization for days or months. An antiviral called cidofovir was used as a treatment but is associated with significant toxicities.
Recognizing that these viral infections can profoundly impact patient healing, Rezvani and her research team directed the development of antiviral T-cell therapies with the support of the MDS and AML Moon Shot, part of the institutions Moon Shots Program, a collaborative effort to quickly develop scientific discoveries into meaningful clinical improvements that save patients lives.
Starting with blood samples taken from healthy donors, the study team can isolate T cells and grow them to specifically recognize and target an assortment of antigens located on the BKV. These cells are expanded in the clinical good manufacturing practice (GMP) lab, under the direction of Elizabeth J. Shpall, M.D., professor of Stem Cell Transplantation and Cellular Therapy. From every donor, the team can fabricate anywhere from 20 to 50 doses of antiviral T cells, which can be stored until needed, Rezvani said.
In an earlier trial published in the New England Journal of Medicine, these researchers showed that BKV-specific T cells may effectively treat disease with the JC virus, a genetically similar polyomavirus which causes progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal brain infection.
BKV-specific T cells get positive results in trialThe current trial enrolled a total of 59 MD Anderson patients experiencing BKV-HC after an allogeneic stem cell transplant. Women accounted for 40.7% of participants and men for 59.3%.
Patients received a single infusion of partially human leukocyte antigen (HLA)-matched T cells, with the option to get additional infusions every 2 weeks, if necessary.
Following infusion, the researchers did not observe any side effects which were probably attributed to the antiviral T cells. Several patients developed delayed cases of low-grade GVHD in the weeks and months after therapy, which were well within the expected rates of GVHD for these patients early after allogeneic stem cell transplant, Rezvani explained.
The median time for patients to have a partial response was 14 days, and the median time to complete response was 21 days. The estimated probability of achieving a complete response was almost 70% by day 45, indicating continuous activity of the infused cells. Responses were durable and no patients saw their symptoms return after a formerly achieved response.
After analyzing participants on the trial, the researchers determined that expansion of the infused T was positively correlated with individual responses.
Were extremely encouraged by the safety of the treatment and the fast answers we have seen in the vast majority of patients, Rezvani said. Because this method is so safe, we have been able to provide this therapy as an outpatient procedure as soon as patients start developing symptoms. This has been life-changing for the patients weve been able to treat thus far.
Ultimately, the researchers aim to validate these findings at a multi-institutional research and bring this treatment option to many more patients in need.
A complete list of cooperating authors and their disclosures are available with the full paper here. In addition to the Moon Shots Program, the study was supported by the National Institutes of Health (R01CA211044-05, CA016672).
Olson, Z.,et al.(2021) Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation.Journal of Clinical Oncology.doi.org/10.1200/JCO.20.02608.
Read the original here:
- FDA Responds to Creative Medical Technology Holdings Regarding Its ImmCelz IND for Stroke Treatment - KPVI News 6 - May 14th, 2021
- Duluth health center specializes in regenerative medicine, hormone replacement therapy - Duluth News Tribune - May 14th, 2021
- Dr. Krger on Toxicities Associated With Allogeneic Stem Cell Transplant in Myeloma - OncLive - May 14th, 2021
- Magenta Therapeutics Announces Positive Preliminary Results from Phase 2 Clinical Trial of MGTA-145 in Multiple Myeloma and Provides an Update on its... - May 14th, 2021
- Genenta Phase I/II Glioblastoma Data at ASGCT Show Temferon Delivered Tumor-Focused Interferon ExpressionData presented at the 2021 American Society... - May 14th, 2021
- ViaCyte To Participate In World Medical Innovation Forum Panel On Future Of Cell Therapy For Type 1 Diabetes - PRNewswire - May 14th, 2021
- Omeros' Narsoplimab Pivotal Trial Data to Be Shared as an Oral Presentation at the European Hematology Association Congress - Business Wire - May 14th, 2021
- Magenta Therapeutics to Participate in Upcoming Healthcare Investor Conferences in May - Business Wire - May 14th, 2021
- Outlook for multiple myeloma: Figures and factors that affect it - Medical News Today - May 14th, 2021
- Global Regenerative Medicine for Cartilage Market Report 2021: Companies are Continuously Focusing on Introducing New Technologies to Survive in the... - May 14th, 2021
- UB celebrates 175th anniversary of its origins in study of medicine - UB Now: News and views for UB faculty and staff - University at Buffalo Reporter - May 14th, 2021
- Stem cell therapy for COVID-19 and ARDS - News-Medical.Net - May 7th, 2021
- Experimental COVID-19 lung treatment being tested at Ontario hospitals - CityNews Toronto - May 7th, 2021
- EP. 4: Optimizing Patient Selection for CAR T-Cell Therapy - OncLive - May 7th, 2021
- Could stem cells improve the outcome of ARDS in severe COVID-19? - News-Medical.Net - May 7th, 2021
- Motixafortide Reaches Primary End Point of Improved Stem Cell Mobilization in Multiple Myeloma Trial - Cancer Network - May 7th, 2021
- Restricting the Growth and Spread of Head and Neck Cancers - Technology Networks - May 7th, 2021
- The global stem cell therapy market is projected to reach USD 401 million by 2026 from - GlobeNewswire - May 7th, 2021
- UCLA team discovers how to restrict growth, spread of head and neck cancers | UCLA - UCLA Newsroom - May 7th, 2021
- NUS scientists found a key element that affects how genes are expressed in blood stem cells - Newswise - May 7th, 2021
- Citius Pharmaceuticals to Present Mino-Lok and COVID-related Respiratory Treatment Update at Benzinga Global Small Cap Conference on Thursday, May 13... - May 7th, 2021
- Mesoblast says its stem cell treatment saved lives of severely ill COVID patients - Stockhead - May 2nd, 2021
- Antiviral T cells safe, effective as off-the-shelf therapy for painful complication after stem cell transplants - News-Medical.Net - May 2nd, 2021
- Desperate family of boy, 9, with leukaemia have 10 days to save his life... - The Sun - May 2nd, 2021
- Orchard Therapeutics Announces Multiple Presentations at the 24th Annual Meeting of the American Society of Gene & Cell Therapy - GlobeNewswire - May 2nd, 2021
- Investigating CAR T-Cell Therapy for Use in Different Disease Types - Targeted Oncology - May 2nd, 2021
- Enhanced inhibition of tumor growth using TRAIL-overexpressing adipose-derived stem cells in combination with the chemotherapeutic agent CPT-11 in... - May 2nd, 2021
- Thomas Smeenk on Hemostemix's autologous stem cell therapy technology and why some call it 'the fountain of youth' - InvestorIntel - April 28th, 2021
- Monitoring levels of vimentin-positive circulating cancer stem cells and tumor cells in patients with advanced EGFR-mutated non-small cell lung cancer... - April 28th, 2021
- Fate Therapeutics Announces Four Presentations at the 2021 ASGCT Annual Meeting - GlobeNewswire - April 28th, 2021
- Therapeutic Solutions International Reports Regression of Established Tumors by Combining its Cancer Blood Vessel Targeting Immunotherapy with Low... - April 28th, 2021
- A review of baculovirus vectors in gene therapy | BTT - Dove Medical Press - April 28th, 2021
- Stem Cell Therapy for COPD: Hope and Exploitation - DocWire News - April 26th, 2021
- Axion BioSystems Announces Formation of Scientific Advisory Board - Business Wire - April 26th, 2021
- Global Cell Therapy Market By Therapy Type, By Therapeutic Area, By End User, By Cell Type, By Regional Outlook, Industry Analysis Report and... - April 24th, 2021
- Pure Red Cell Aplasia following ABO-Mismatched Allogeneic Hematopoietic Stem Cell Transplantation: Resolution with Daratumumab Treatment - DocWire... - April 24th, 2021
- Advancing the Development of Safe and Effective Regenerative Medicine Products | FDA - FDA.gov - April 24th, 2021
- New method helps map the specialized diversity and spatial location of cells within a tissue or tumor - News-Medical.Net - April 24th, 2021
- Chimeric embryo may have medical implications The Campus - The Campus - April 24th, 2021
- Survival and treatment patterns of patients with relapsed or refractory multiple myeloma in France - a cohort study using the French National... - April 24th, 2021
- Guenther Koehne, MD, Highlights Recent Advancements in the Treatment of Blood Cancers - Oncology Learning Network - April 24th, 2021
- Rinri Therapeutics raises 10 million to advance stem cell therapy for hearing loss - The Star - April 24th, 2021
- Cancer Diagnosis in Patient Given LentiGlobin Revised to Severe Anemia - Sickle Cell Anemia News - April 24th, 2021
- Hodgkin lymphoma: Symptoms, outlook, treatment, and more - Medical News Today - April 24th, 2021
- Tissue Repair, Mitochondrial Function and Wound Healing Explored in 2021 APS Presidents Symposium - Newswise - April 24th, 2021
- Axion BioSystems Announces Formation of Scientific Advisory Board - BioSpace - April 20th, 2021
- Avalon GloboCare is seeking to tap the power of cells to fight cancer and coronavirus - Proactive Investors USA - April 20th, 2021
- Rinri Therapeutics Raises 10 million from Existing Investors and UK Future Fund to Advance its Novel Stem Cell Therapy to Restore Hearing Loss -... - April 20th, 2021
- Global Regenerative Medicines Market 2020-2030: Opportunities in Drug Approvals and Strong Pipeline of Cell and Gene Therapies & Multiple... - April 20th, 2021
- FDA Grants Orphan Drug Status to Novel IRAK4 Inhibitor in AML and MDS - Targeted Oncology - April 20th, 2021
- Vertex Drops $900 Million to Expand Partnership with CRISPR Therapeutics - BioSpace - April 20th, 2021
- Kaleido Biosciences Announces Collaboration with Robert Jenq, MD, to Explore Potential of its Microbiome Metabolic Therapies (MMT) in Preventing... - April 20th, 2021
- Partner Content | Being bionic: the future of regenerative medicine - TheSpec.com - April 14th, 2021
- Ohio State Recruits Top Oncologist to Expand Cell Therapy Program, Lead Bone Marrow Transplant Services - Wexner Medical Center - The Ohio State... - April 14th, 2021
- Leukemia Cutis: Symptoms and Treatment - Healthline - April 14th, 2021
- Green: Variants and outbreaks continue to put stress on hospitals - Vermont Biz - April 14th, 2021
- CRISPR Therapies Pipeline Insights 2021: Analysis of Key Companies, Emerging Therapies, Recent Happenings and Futuristic Trends - GlobeNewswire - April 14th, 2021
- Consortium to investigate role of neurofilament light chain in neurodegenerative diseases Washington University School of Medicine in St. Louis -... - April 14th, 2021
- Man's heart healed by stem cell therapy and love of an old flame - Leeds Live - April 12th, 2021
- New pediatric cancer treatment method being used in Iran - Tehran Times - April 12th, 2021
- Personalized Cancer Vaccine Shows Early Efficacy in Patients With Diverse Tumor Types - Technology Networks - April 12th, 2021
- 1000th Stem Cell Transplant Given to Girl Who Is One in a Million - Stanford Children's Health Blog - Stanford Children's Health - April 10th, 2021
- Home : Stem Cell Treatments - April 10th, 2021
- Researchers discover unique regenerative property of cells in the early human embryo - News-Medical.net - April 10th, 2021
- Study reveals sex-differences in aging of the brain stem cell niche - News-Medical.net - April 10th, 2021
- Antibiotics need further study in cancer treatments - Chicago Daily Herald - April 10th, 2021
- Prolonged infection and inflammation drain immune responses as we age - Baylor College of Medicine News - April 10th, 2021
- Toward a transformative therapy for sickle cell patients - News-Medical.Net - April 10th, 2021
- Mass. Residents 55+ Or With 1 Medical Condition Can Now Get COVID Vaccine | WBZ NewsRadio 1030 - iHeartRadio - April 6th, 2021
- Mortality from Multiple Myeloma Within One Year Following Autologous Stem Cell Transplantation: Defining an Ultra-high Risk Population - DocWire News - April 6th, 2021
- BioRestorative Therapies Announces Appointment of Nickolay V. Kukekov, Ph.D to its Board of Directors - BioSpace - April 6th, 2021
- LGL Leukemia: Overview, Symptoms, and Treatment - Healthline - April 3rd, 2021
- Novel T-Cell Therapy MT-401 Under Evaluation in Post-Transplant AML - OncLive - April 3rd, 2021
- Funding the Next Generation of Cancer Therapies - Genetic Engineering & Biotechnology News - April 3rd, 2021
- Do Therapies for Alzheimer's & Parkinson's that Clear Abnormal Brain Proteins Make the Diseases Worse? - BioSpace - April 3rd, 2021
- Allogeneic hematopoietic stem cell transplantation for therapy-related myeloid neoplasms following treatment of a lymphoid malignancy - DocWire News - April 1st, 2021
- Insulin 100: How the road to a diabetes cure is yielding better treatments - News@UofT - April 1st, 2021
- The Government's Watchful Eye on Fraud Stemming from Stem Cell Therapy - Lexology - April 1st, 2021
- Introducing a neuro regenerative gene into mice with spinal cord injury improves motor function - News-Medical.net - April 1st, 2021
- Gracell Biotechnologies Announces Enrollment of First Patient in Registrational Phase 1/2 Clinical Study for GC007g, an Allogeneic CAR-T Cell Therapy... - April 1st, 2021