CAR T-cell Therapy

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.

Leaked data from an abstract scheduled to be presented at the 2023 EHA Hybrid Congress showed that ciltacabtagene autoleucel demonstrated a 74% reduction in the risk of disease progression or death compared with standard therapy in patients with relapsed/refractory multiple myeloma who received 1 to 3 prior lines of therapy.

The allogeneic anti-CD70 CAR T-cell therapy ALLO-316 elicited signals of antitumor activity and showed a tolerable safety profile in patients with advanced or metastatic clear cell renal cell carcinoma.

Surbhi Sidana, MD, discusses the real-world safety and efficacy of ide-cel in patients with multiple myeloma and renal impairment, and emphasizes the importance of including this population in future clinical trials examining novel therapies in this disease.

CAR T-cell therapies have transformed the treatment landscape of multiple hematologic malignancies since they first rose to prominence, but they are associated with a high financial cost, both for the patient and the health care institution that provides them.

The FDA has granted a fast track designation to CB-011, a CRISPR-edited allogeneic CAR T-cell therapy developed by Caribou Biosciences, for the treatment of patients with relapsed/refractory multiple myeloma.

The FDA has granted a fast track designation to SynKIR-110 for the treatment of patients with mesothelioma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of select patients with large B-cell lymphoma who relapsed within 12 months from completion of or developed refractory disease to frontline chemoimmunotherapy.

Craig Sauter, MD, discussed the common limitations of CAR T-cell therapy through timely referral and the existing questions for patients with LBCL who progress on CAR T-cell therapy.

Jeffery Zonder, MD, discusses the need for expanding the armamentarium of targeted therapies for patients with relapsed/refractory multiple myeloma.

Investigators identified a set of microbiome-based biomarkers that may be used to optimize patient selection or increase personalization of treatment for patients with B-cell lymphoma receiving CAR T-cell therapy.

Jeffery Zonder, MD, discusses the process of choosing between CAR T-cell therapy and bispecific antibody approaches for the treatment of patients with relapsed/refractory multiple myeloma.

Abhinav Deol, MD, discusses the current limitations of CAR T-cell therapy in the treatment of patients with relapsed/refractory multiple myeloma.

Axicabtagene ciloleucel produced a statistically significant improvement in overall survival compared with standard-of-caretherapy in patients with relapsed/refractory large B-cell lymphoma, according to data from the ZUMA-7 trial.

A real-world analysis exploring the outcomes of inpatient vs outpatient administration of CAR T-cell therapy in patients with mantle cell lymphoma and follicular lymphoma demonstrated both similarities and some differences between the 2 patient populations.

Mayur Narkhede, MD, discusses the early findings for the use of siltuximab to manage cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome in patients following CAR T-cell therapy and expands on the next steps for investigating this agent during the phase 2 trial.

Nirav N. Shah, MD, explains the choice to evaluate LV20.19 CAR in MCL, key efficacy and safety data from the follow-up study of this agent, and ongoing efforts to potentially expand its use across other B-cell malignancies.

Bellicum Pharmaceuticals has discontinued 2 phase 1/2 trials evaluating the safety and preliminary efficacy of the GoCAR T-cell products BPX-601 and BPX-603 in combination with rimiducid in heavily pretreated patients with advanced solid tumors following an assessment of the risk/benefit profile of the combination of BPX-601 and rimiducid.

Matthew Frank, MD, PhD, discusses the rationale for investigating CD22-directed CAR-T cell therapy in adult patients with large B-cell lymphoma who relapsed after or were refractory to CD19-directed CAR T-cell therapy.

Brexucabtagene autoleucel demonstrated a survival benefit in patients with relapsed/refractory B-cell acute lymphoblastic leukemia regardless of prior lines of treatment or exposure to blinatumomab or allogeneic stem cell transplant, according to data from subgroup analyses of the ZUMA-3 trial.

ADI-001, a first-in-class, allogeneic gamma delta1 CAR T-cell therapy, elicited responses and demonstrated a favorable safety profile in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

Treatment with brexucabtagene autoleucel in the standard-of-care relapsed/refractory mantle cell lymphoma setting provided an efficacy and safety profile consistent with data reported in the phase 2 ZUMA-2 trial.

The FDA has granted regenerative medicine advanced therapy and fast track designations to equecabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma.

A renewed focus on dismantling the barriers and closing gaps in care will aid in the mission to drive down the rate of cancer mortality and incidence across disease states.

Andre H. Goy, MD, discusses key findings from an assessment of durable responses in the phase 2 ZUMA-2 trial in relapsed/refractory mantle cell lymphoma.

Idecabtagene vicleucel improved progression-free survival compared with standard combination regimens in patients with relapsed/refractory multiple myeloma after 2 to 4 prior lines of therapy and who were refractory to their last regimen, according to results from the phase 3 KarMMa-3 trial.

The CAR T-cell therapy brexucabtagene autoleucel produced a median overall survival of 26 months in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.