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According to Federal Register notices, the guidance documents are updated versions of drafts originally published in March 2022.

The assistant attending physician and bone marrow transplant specialist at Memorial Sloan Kettering Cancer Center discussed updated data on GDA-201 plus rituximab.

The committee is set to discuss idecabtagene vicleucel’s sBLA on March 15, 2024.

The assistant professor in the department of pediatrics at the University of Florida College of Medicine discussed also discussed the need to set standard guidelines regarding potential fertility issues for CAR-T treatment.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.

Catch up on any of the key data updates you may have missed last month, with coverage highlights from the CGTLive™ team.

The endowed chair in cellular and molecular medicine at Boston Children’s Hospital discussed past, present, and potential future applications of siRNA in the treatment of various diseases.

Welcome to CGTLive®’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.

The Assistant Professor of Medicine at Weill Cornell Medical College shared the background rationale of her retrospective analysis presented at Tandem 2024.

The patient is doing well so far and may receive a booster dose of the TAC cell therapy.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The long-term data comes from 2 cohorts in the phase 2 CARTITUDE-2 clinical trial.

The hematology coordinator for pharmacy at Froedtert and the Medical College of Wisconsin discussed the advantages of each of the 2 modalities in the third and second line settings.

The data comes from an expanded access protocol (EAP; JCAR017-EAP-001) that included 96 patients in total who were treated with the nonconforming product.

Juliane Gust, MD, PhD, an assistant professor of neurology at University of Washington, Seattle Children's, discussed a study that is currently underway via the NIH’s CARnation Consortium that will seek to address this gap in knowledge.

The transplant infectious diseases physician at Dana-Farber Cancer Institute discussed a case study she presented at the 2024 Tandem Meetings.

Chris McDonald, senior vice president and global head of technical operations, Kite Pharma, discussed the recent axi-cel manufacturing change approval.

The associate professor of medicine at Medical College of Wisconsin discussed clinical results from patients with CLL and Richter’s transformation treated with CD19/CD20-targeted CAR-T LV20.19.

Going forward, the dose for patients with CLL has been reduced to 1x106 cells/kg.

Differences between IEC and non-IEC post-relapse outcomes showed some significance in PFS but not in ORR.

The physician from St. Jude Children’s Research Hospital discussed the importance of involvement from patients and families while researching the long-term impact of CAR-T.

The researchers are continuing to investigate in vivo efficacy to pave the way to IND-enabling studies.

The assistant clinical director of the Center for Gene and Cellular Immunotherapy at Washington University in St. Louis discussed Atara Biotherapeutics' tabelecleucel and AlloVir’s posoleucel.

Patients with high bone marrow burden and CNS/non-CNS EMD were found to experience the worst OS and EFS outcomes.
























