FDA Manufacturing Data Request Delays Omidubicel BLA Submission
The request aims to ensure the comparability of omidubicel manufactured at different sites.
CAR T Therapy Promise in Relapsed Diffuse Large B-Cell Lymphoma: Jason Westin, MD
The director of Lymphoma Clinical Research at the University of Texas MD Anderson Cancer Center, discussed the future of DLBCL treatment.
GeneTherapyLive’s Weekly Rewind – November 12, 2021
Review top news and interview highlights from the week ending November 12, 2021.
CAR Macrophages Well-Tolerated, May Reprogram Tumor Microenvironments
The first in-human study of CAR macrophages has dosed 2 participants so far.
Cohort Data From TRANSCEND-CLL-004 of Liso-Cel: William G. Wierda, MD
The associate professor of medicine from MD Anderson Cancer Center discussed data from the phase 1 cohort of liso-cel combined with ibrutinib.
Tmod CAR T-Cell Therapy Offers Precise Targeting of Solid Tumors
The BASECAMP-1 study is identifying patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH) for future use of these therapies.
CAR T-Cell Therapy Plus Amplifying Vaccine Shows Initial Safety, Efficacy in Solid Tumors
Three patients dosed had tumors shrinkages of 18%, 21%, and 27%.
Insights into Brexucabtagene Autoleucel R/R B-ALL Approval: Bijal Shah, MD
The hematologist from Moffitt Cancer Center discussed the FDA approval of brexucabtagene autoleucel in relapsed/refractory B-cell acute lymphoblastic leukemia.
TCR T-Cell Therapy Shows Efficacy Across Solid Tumor Types
Data from the IMA203 trial were presented at the SITC 2021 annual meeting.
Advancing Natural Killer Cell Therapies for Hematologic Malignancies
Sonny Hsiao, PhD, chief executive officer, president and cofounder, Acepodia, discussed the company’s future research and plans.
Cilta-Cel Safety Profile in Multiple Myeloma: Adam D. Cohen, MD
The director of Myeloma Immunotherapy at University of Pennsylvania discussed ciltacabtagene autoleucel's safety profile.
Photoreceptor Precursor Cells' Potential to Treat Inherited Retinal Diseases
Investigators are planning a first-in-man clinical trial for photoreceptor precursor transplant in Singapore.
Gavo-Cel to Be Evaluated With Nivolumab, Ipilimumab for Solid Tumors
TCR² Therapeutics is collaborating with Bristol Myers Squibb to evaluate combination therapies in a phase 2 trial.
Potential of NK Cells in Multiple Myeloma: Nina Shah, MD
The hematologist and oncologist from UCSF Helen Diller Family Comprehensive Cancer Center discussed the potential utility of natural killer cells in multiple myeloma.
Gene Therapy Well-Tolerated in Fabry Disease
Primary efficacy data released by Sangamo Therapeutics showed that above normal α-Gal A activity was maintained for up to a year after treatment.
Socioeconomic Factors Affect Stem Cell Transplant in Mantle Cell Lymphoma
Yazeed Sawalha, MD, hematologist, Ohio State University Comprehensive Cancer Center, discussed how socioeconomic factors can affect use of ASCT in mantle cell lymphoma.
Challenges in Developing Gene Therapy for AADC Deficiency: Paul Wuh-Liang Hwu, MD, PhD
The professor from National Taiwan University Hospital discussed the challenges of working with a rare disease.
Autologous HSCT's Role in the Mantle Cell Lymphoma Treatment Landscape
Autologous hematopoietic stem-cell transplantation maintained its long-term efficacy over interferon alfa in patients with mantle cell lymphoma.
Developing Gene Therapies for Rare Diseases
The chief executive officer of Rocket Pharmaceuticals, Gaurav Shah, MD, discussed the company’s lead programs and future plans.
New Project Aims to Increase CAR T Safety, Availability
A new project is manufacturing a “purified” version of CAR-T-cells currently used to treat types of lymphoma and leukemia.
Real-World Efficacy of Brexucabtagene Autoleucel in Mantle Cell Lymphoma: Luhua Wang, MD
The professor from University of Texas MD Anderson Cancer Center discussed the real-world efficacy of the first CAR T therapy for the treatment of mantle cell lymphoma.
GeneTherapyLive’s Weekly Rewind – November 5, 2021
Review top news and interview highlights from the week ending November 5, 2021.
CAR T Therapy as a New Option in Non-Hodgkin Lymphoma: Michael R. Bishop, MD
The hematological oncologist from University of Chicago Medicine discussed chimeric antigen receptor T cells therapy in non-Hodgkin lymphoma.
Novel Therapies Reduce the Need for Chemotherapy in Leukemias and Lymphomas
Dipenkumar Modi, MD, discussed novel treatment options in leukemias and lymphomas.
Gene Therapies Show Efficacy in Fabry Disease, Choroideremia
4D Molecular Therapeutics announced positive data from trials assessing 2 of their gene therapies.
Future Research With NK and CAR T Therapy in Multiple Myeloma: Irene Ghobrial, MD
The director at Dana-Farber Cancer Institute discussed future efforts to prevent the development of multiple myeloma.
Tisagenlecleucel Granted Priority Review for R/R Follicular Lymphoma
The FDA also accepted a Type II Variation for the use of tisagenlecleucel in patients with R/R FL following 2 prior lines of treatment.
Improving Cell Therapy Manufacturing Through Strategic Partnerships
Paul Lammers, MD, MSc, president and chief executive officer, Triumvira Immunologics, discussed the challenges of manufacturing cell therapies.
FDA Extends Cilta-Cel BLA PDUFA Date for R/R Multiple Myeloma
The FDA has pushed cilta-cel's BLA PDUFA date back by almost 4 months.
Improving Outcomes in AADC Deficiency With Gene Therapy: Paul Wuh-Liang Hwu, MD, PhD
The professor from National Taiwan University Hospital discussed further research he would like to do with the gene therapy PTC-AADC.
