CAR T-Cell Therapy

The safety, tolerability, and preliminary efficacy of the anti-HER2 CAR macrophage therapy, CT-0508, will be investigated in patients with solid tumors and HER2 overexpression, as part of a first-in-human phase 1 study.

Resistance to CD19-directed CAR T-cell therapy was associated with molecular characteristics identified in pediatric patients with acute lymphoblastic leukemia.

The T-cell attributes of axicabtagene ciloleucel impacted tumor burden, efficacy outcomes, peak levels of proinflammatory cytokines, and toxicities such as neurologic events and cytokine release syndrome in patients with relapsed/refractory large B-cell lymphoma.

GD2-directed CAR T-cell therapy demonstrated prolonged periods of radiographic and clinical improvement in pediatric and young adult patients with H3K27M-mutated diffuse intrinsic pontine gliomas and spinal diffuse midline gliomas.

Off-the-shelf anti-mesothelin T-cell receptor fusion construct T cells demonstrated prolonged persistence and efficacy in vivo against mesothelin-expressing tumors in mice, compared with gavocabtagene autoleucel.

The China National Medical Products Administration’s Center for Drug Evaluation has granted a breakthrough therapy designation to relmacabtagene autoleucel for use in the treatment of patients with mantle cell lymphoma.

The European Commission has granted marketing authorization to the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for use in adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic treatment.

The FDA has granted a fast track designation to the multigenic autologous CAR T-cell therapy PRGN-3006 for use as a potential therapeutic option in patients with relapsed or refractory acute myeloid leukemia.

Lori A. Leslie, MD, discusses the FDA approval of axicabtagene ciloleucel for second-line relapsed/refractory large B-cell lymphoma.

The FDA has approved axicabtagene ciloleucel for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

Investigators at the Perelman School of Medicine at the University of Pennsylvania have recently initiated a clinical trial evaluating a novel CAR T-cell therapy in an effort to fill an unmet need for systemic treatment for patients with advanced incurable medullary thyroid cancer.

The Ministry of Health, Labour, and Welfare has accepted a supplemental new drug application for lisocabtagene maraleucel for the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of tisagenlecleucel for use in adult patients with relapsed/refractory follicular lymphoma following 2 lines of systemic treatment.

The FDA has approved ciltacabtagene autoleucel for the treatment of adult patients with relapsed/refractory multiple myeloma, following 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Lori A. Leslie, MD, and Andre H. Goy, MD, share strategies for when CAR T-cell therapy is not an option.

Lori A. Leslie, MD, and Andre H. Goy, MD, discuss approaches to CAR T-cell therapy.

Lori A. Leslie, MD, and Andre H. Goy, MD, discuss optimal strategies for CAR T-cell–related adverse effects.

Lori A. Leslie, MD, and Andre H. Goy, MD, discuss retreatment with CAR T-cell therapy.

Lori A. Leslie, MD, and Andre H. Goy, MD, discuss next steps with CAR T-cell therapy.

Sundar Jagannath, MBBS, discusses the significance of the FDA approval of ciltacabtagene autoleucel, important adverse effects to be aware of, and shared his thoughts on where the treatment fits into the current and future treatment paradigms.

Oliver Van Oekelen, MD, MSc, discusses findings from a retrospective study that evaluated treatment and efficacy outcomes in patients with relapsed or refractory multiple myeloma who experienced disease progression after BCMA-directed CAR T-cell therapy.

The FDA has approved ciltacabtagene autoleucel for the treatment of adult patients with relapsed and/or refractory multiple myeloma following 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of the CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma in whom frontline therapy has failed.

The FDA has placed a clinical hold on a phase 1 trial evaluating the safety and efficacy of the autologous CAR T-cell product LB1901 as a potential therapeutic option in adult patients with relapsed or refractory T-cell lymphoma.

The FDA has granted an orphan drug designation to the off-the-shelf natural killer cell therapy CYNK-101 as a potential treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.