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Statistically significant differences were seen in global health status, pain, and fatigue.

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee again voted in favor of the risk-benefit of bluebird bio's gene therapy candidate.

Review top news and interview highlights from the week ending June 10, 2022.

Three of 6 patients have an ongoing response.

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted in favor of the benefits of bluebird bio's eli-cel in patients with cerebral andrenoleukodystrophy despite substantial safety concerns.

Data from a phase 1/2a study showed notable response rates in patients who had received a median of 5 prior lines of therapy.

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

The chimeric antigen receptor-modified autologous T cells targeting CLDN18.2 had a manageable safety/tolerability profile and promising efficacy.

100% overall response and complete response rates were seen in patients treated with prior CD19 CAR T-cell therapy.

Overall response rate was 41.7% and median progression free survival was 7.2 months.

Jason Westin, MD, FACP, leader, DLBCL research team, MD Anderson Cancer Center, discussed results from the ZUMA-7 trial at ASCO 2022.

The phase 1/2 trial of VX880 remains on clinical hold in the US.

The findings suggest that less disadvantaged patients with high disease burden may have greater ability to advocate for CAR T-cell therapy.

69% of patients followed up for at least 1 year continue to have an ongoing response.

Three of the 9 patients who received the infusion demonstrated best overall response of Stable Disease, and investigators determined dose level 2 to be the biologically effective dose.

Niels van de Donk, MD, PhD, professor, Amsterdam University Medical Centers, discussed positive findings from cohort B of the CARTITUDE-2 study.

Regardless of bone marrow cellularity, bone marrow minimal residual disease (MRD) negativity at month 1 correlated with deep response and prolonged PFS.

Melissa Alsina, MD, gave a talk on novel CAR therapies, targets, and approaches at the 2022 ASCO meeting.

Findings from the US-based study align with results from a phase 1b/2 study completed in China of CT041 in patients with gastric and gastroesophageal junction adenocarcinoma.

The assistant professor of medicine at University of Pennsylvania Hospital stressed the importance of tumor sequencing.

The phase 1, open-label, single-arm study demonstrated favorable safety and robust efficacy for the autologous GPRC5D-directed CAR-T cell therapy.

Data were presented at ASCO 2021 and EHA 2021 for the initial 19 patients. Now, investigators are painting a fuller picture with an additional 9.

The BASECAMP-1 study is currently enrolling participants to explore the feasibility of manufacturing a novel CAR T-cell therapy with a target antigen activator and a HLA LOH-based blocker.

Higher-dose lymphodepleting regimens led to higher toxicity but high response rates.

Cohort A of the CARTITUDE-2 study is evaluating cilta-cel safety and efficacy in patients with multiple myeloma who received 1 to 3 prior lines of therapy.

“Therapy was found to be safe and tolerable. This initial data formed the basis for further exploration that is currently ongoing in the IGNYTE-ESO study,” investigator Sandra P. D’Angelo, MD, tells CGTL.

The associate professor of medicine at Medical College of Wisconsin discussed advantages of the ARC-SparX platform.

High response rates were seen in patients that would not meet ZUMA-2 eligibility criteria.