CAR T-Cell Therapy

Treatment with NKX101 led to a best composite complete response rate of 67% in patients with relapsed/refractory acute myeloid leukemia, according to updated data from a dose-expansion cohort of an ongoing phase 1 trial.

Nikhil C. Munshi, MD, discusses the significance of the FDA approval of cilta-cel in patients with multiple myeloma, shares the long-term findings from the pivotal CARTITUDE-1 trial, and highlights future directions for CAR T-cell therapy in this disease.

The CAR T-cell therapy AUTO4 was not associated with dose-limiting toxicities and led to early indications of efficacy in patients with relapsed/refractory TRBC1-positive peripheral T-cell lymphoma.

The novel, autologous, anti-CD19 CAR T-cell therapy anbalcabtagene autoleucel produced durable responses and was well tolerated in patients with relapsed/refractory large B-cell lymphoma.

The FDA has placed a hold on the clinical program for the investigational new drug CART-ddBCMA for the treatment of patients with relapsed/refractory multiple myeloma.

A single administration of lisocabtagene maraleucel provided deep and durable remissions when used as third-line treatment in patients with relapsed or refractory follicular lymphoma, including those with high-risk features.

The CAR T-cell therapy lisocabtagene maraleucel produced rapid and durable responses in heavily pretreated patients with relapsed/refractory mantle cell lymphoma.

Claire Roddie, MD, discusses the rationale for investigating obecabtagene autoleucel in patients with relapsed/refractory B-cell acute lymphoblastic leukemia, details the key topline findings from the FELIX trial, and provides insights on unmet needs that remain for this patient population.

The real-world efficacy and safety of brexucabtagene autoleucel were similar to the outcomes seen in the phase 2 ZUMA-2 trial, regardless of patients’ treatment history, according to results from a real-world subgroup analysis of patients with relapsed/refractory mantle cell lymphoma.

Swetha Kambhampati, MD, discusses key findings from an analysis of real-world efficacy outcomes with brexucabtagene autoleucel in heavily pretreated patients with relapsed/refractory mantle cell lymphoma.

Mary “Nora” Disis, MD, discusses the results of a phase 1/1b study of PRGN-3005 autologous UltraCAR T cells in patients with advanced stage platinum-resistant ovarian cancer.

The FDA has granted priority and standard review designations to the biologics license applications for exagamglogene autotemcel for the treatment of patients with sickle cell disease and transfusion-dependent beta thalassemia, respectively, marking the first CRISPR gene editing filings to be accepted for review by the FDA.

A supplemental biologics license application seeking the approval of ciltacabtagene autoleucel for use in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have previously received at least 1 line of therapy, including a proteasome inhibitor and an immunomodulatory agent, has been submitted to the FDA.

Second-line treatment with axicabtagene ciloleucel significantly improved overall survival compared with high-dose therapy plus autologous stem cell transplant in patients with early relapsed or refractory large B-cell lymphoma.

Ciltacabtagene autoleucel significantly improved progression-free survival over standard-of-care pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.

The BCMA- and CD19-targeted CAR T-cell therapy GC012F continued to demonstrate a favorable safety profile with no new safety signals, and it elicited deep and durable responses in patients with relapsed/refractory multiple myeloma.

Claire Roddie, MD, discusses the patient population and topline efficacy findings from the phase 1/2 FELIX trial, which is investigating the CD19-directed CAR T-cell therapy obecabtagene autoleucel in patients with relapsed/refractory adult B-cell acute lymphoblastic leukemia.

The CAR T-cell therapy PHE885 produced responses and high minimal residual disease negativity rates with no new safety signals in patients with relapsed/refractory multiple myeloma.

When manufactured via automated process the CLDN6-directed CAR T-cell therapy, BNT211, demonstrated encouraging signs of activity and a manageable safety profile with or without the addition of CLDN6-encoding mRNA vaccine in patients with CLDN6-positive relapsed/refractory advanced solid tumors.

Brexucabtagene autoleucel elicited high rates of complete remission with minimal residual disease negativity in real-world patients with relapsed or refractory B-cell acute lymphoblastic leukemia who received the CAR T-cell product as post-approval, standard-of-care treatment, according to data from a retrospective study.

Obecabtagene autoleucel was associated with a 76% complete response (CR)/CR with incomplete count recovery rate in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.

The investigational CAR T-cell therapy GD2-CART01 showed preliminary antitumor activity and safety in pediatric patients with relapsed or refractory high-risk neuroblastoma, according to data from a phase 1/2 trial.

The European Commission has approved lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Looking to replicate the impressive findings with CAR T-cell therapies observed in patients with hematologic malignancies, investigators have initiated the BASECAMP-1 trial, with the hope of identifying patients with advanced solid tumors who will be suitable candidates for treatment in a subsequent trial evaluating the investigational agent A2B530.