CAR T-Cell Therapy

Taiga Nishihori, MD, discussed the current outpatient administration model of cilta-cel among patients with relapsed/refractory multiple myeloma.

Significant progress has been made since the approval of the first CAR T-cell therapy, but there is still tremendous room for improvement.

The CARTITUDE-4 study that found that treatment with cilta-cel led to a statistically significant and clinically meaningful improvement in overall survival among patients with relapsed and lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.

Secondary malignancies following CAR T-cell therapy have been a known risk, but an FDA investigation and call for labeling change have renewed interest.

Rhonda Henschel, MBA, discussed the challenges and considerations for community oncology practices looking to implement cellular therapy programs.

Following an investigation that began in November 2023, the FDA now requires boxed warnings regarding T-cell malignancies on all BCMA- and CD19-directed T-cell products.

The approval follows a unanimous vote by the FDA’s Oncologic Drugs Advisory Committee where they decided the benefits of cilta-cel outweigh the risks for this patient population.

Idecabtagene vicleucel (ide-cel) demonstrated a 51% reduction in risk of disease progression or death in patients with relapsed or refractory multiple myeloma.

Until recently, the CAR gene modification has been focused on T cells, thought for decades to be the main effector population for controlling cancer or for harnessing cancer immunotherapy.

Natural killer–cell therapies are increasingly being explored as an alternative and promising approach to immunotherapy.

A novel CAR T-cell therapy being developed at City of Hope offers a potential new treatment avenue for patients with recurrent glioblastoma and high-grade glioma. 

The result of the FDA's Oncologic Drug Advisory Committee vote on idecabtagene vicleucel for the proposed indication is favorable.

During an Oncologic Drugs Advisory Committee Meeting, the FDA found that ciltacabtagene autoleucel has a favorable benefit/risk profile in relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy and are refractory to lenalidomide.

Introducing a checkpoint inhibitor like nivolumab for patients where chimeric antigen receptor T-cell therapy failed in multiple myeloma is a potential area of interest for researchers.

Six CAR T-cell therapies have gained FDA approval across hematologic malignancy settings. These approvals have spurred further exploration for their use in solid tumors.

The novel cell therapy A2B530 is the first logic-gated cell therapy aimed at selectively killing tumor cells and protecting healthy cells in colorectal cancer.

The latest developments across the fields of stem cell transplantation and cellular therapy were presented at the 2024 Tandem Meetings in San Antonio, Texas, from February 21-24, 2024.

A retrospective study of real-world patients showed that immune engager therapies had the best response and progression-free survival rates in patients with multiple myeloma who had a relapse after idecabtagene vicleucel treatment.

A retrospective study demonstrated the feasibility and efficacy of brexucabtagene autoleucel in treating central nervous system involvement in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

A study suggests that a novel CAR T-cell therapy could be a curative treatment for some patients with chronic lymphocytic leukemia, with 25% of responders still in remission after 6 years.

The phase 1 study of HEMO-CAR-T in patients with acute myeloid leukemia can proceed following the lifted clinical hold.

The FDA’s Oncologic Drug Advisory Committee will be held on March 15, 2024, to review data pertaining to the supplemental biologics license application of ide-cel in relapsed or refractory multiple myeloma.

The axicabtagene ciloleucel manufacturing process has received FDA approval for a change to reduce the median turnaround time.

Matthew J. Frigault, MD, MS, discussed follow-up data on the efficacy and safety of CART-ddBCMA for the treatment of patients with relapsed/refractory multiple myeloma, particularly in later-line settings.

Findings from a phase 2 study found that treatment with axicabtagene ciloleucel in relapsed or refractory large B-cell lymphoma led to a complete metabolic response of 71%.

In an interview with Targeted Oncology, Daniel Baker, PhD candidate at the University of Pennsylvania, discussed the growing role for CAR T-cell therapies outside of the oncology field.

Results from the phase 3 ZUMA-7 trial showed superior progression-free survival and overall survival in patients 65 and older with large B-cell lymphoma with axicabtagene ciloleucel compared with standard of care.

Investigators in the MCARTY study reported safety and high response rates in a small number of patients with relapsed/refractory multiple myeloma who received chimeric antigen receptor T-cell therapy designed with a new process to target the D8 binder, meant to improve efficacy in targeting BCMA.

Four outpatient chimeric antigen receptor T-cell therapy programs utilized a virtual care program including remote patient monitoring following T-cell infusion, reducing hospital admissions and helping patients contact nurses during non-clinical hours.

An investigational new drug application for VIPER-101, a chimeric antigen receptor T-cell therapy, has been cleared by the FDA in T-cell lymphoma.