CAR T-cell Therapy

The FDA has received reports of T-cell malignancies in patients who have been treated with CD19- or BCMA-directed autologous CAR T-cell immunotherapies.

Adrienne Phillips, MD, MPH, discusses the impact of CAR T-cell therapy on the treatment paradigm for patients with large B-cell lymphoma, highlighting key advancements in the decision-making process for CAR T-cell therapy selection.

A biologics license application seeking the approval of obecabtagene autoleucel for the treatment of adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia has been submitted to the FDA.

Michael Hurwitz, MD, PhD, discusses the feasibility of utilizing CAR T-cell therapies in patients with solid tumors, such as kidney cancers.

Lori A. Leslie, MD, discusses the benefits of implementing CAR T-cell therapy programs for patients with hematologic malignancies and highlights the successes with administering CAR T-cell therapy that JTCC has experienced.

Adrienne Phillips, MD, MPH, discusses the management of toxicities associated with CAR T-cell therapy across hematologic malignancies.

Md Kamrul Hasan, PhD, discusses the preclinical efficacy and safety of ROR1-specific CAR T-cells in a preclinical mouse model of chronic lymphocytic leukemia.

The FDA’s Oncologic Drugs Advisory Committee will meet to review data from the supplemental biologics license application seeking the approval of idecabtagene vicleucel for use in earlier lines of treatment for patients with triple-class exposed relapsed/refractory multiple myeloma.

The HER2-directed CAR-macrophage therapy CT-0508 displayed a tolerable safety profile and signs of antitumor activity in patients with a variety of solid tumors.

Although not immediately practice changing, CAR T-cell therapy has the potential to become a standard of care for patients with advanced renal cell carcinoma following progression on checkpoint inhibitors and VEGF inhibitors.

Mark Leick, MD, discusses the challenges and limitations associated with the use of CAR T-cell therapy across hematologic malignancies, highlighting how ongoing research may potentially ameliorate present unmet needs.

The FDA has granted priority review to the supplemental biologics license application seeking approval to expand the indication of lisocabtagene maraleucel to include patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a BTK inhibitor and a BCL-2 inhibitor.

Mark Leick, MD, discusses the varying role of CAR T-cell therapy across various hematologic malignancies, elaborating on the cause of its effectiveness in these disease spaces.

Mark Leick, MD, discusses how the emergence of CAR T-cell therapies have affected the treatment paradigms in various hematologic malignancies, expands on how persisting challenges with the use of this type of treatment are being addressed, and details research into the use of CAR T-cell therapy in patients with solid tumors.

The FDA has cleared the investigational new drug application for CHM 2101, a novel CDH17-targeted CAR T-cell therapy, for the treatment of patients with gastrointestinal cancers.

The Claudin-6–directed CAR T-cell therapy, BNT211, showed signs of clinical activity in patients with CLDN6-positive relapsed or refractory solid tumors.

Hemant S. Murthy, MD, discusses the evolving use of CAR T-cell therapy for elderly or frail patients with relapsed/refractory B-cell lymphomas.

Hemant S. Murthy, MD, emphasizes the importance of an accelerated manufacturing process for CAR T-cell therapy, discusses the use of CAR T-cell therapy in older and frail patients, and highlights toxicity management strategies that have implemented and are under evaluation for patients receiving CAR T-cell therapy.

Loretta J. Nastoupil, MD, discusses the rationale for launching the phase 2 TRANSCEND FL trial evaluating lisocabtagene maraleucel in patients with relapsed/refractory follicular lymphoma, highlighting the background for investigating this treatment approach.

J. Randolph (Randy) Hecht, MD, discusses barriers to enrollment in the observational BASECAMP-1 study and the phase 1/2 EVEREST-1 study, which will investigate HLA-A*02 as a target for the novel CAR T-cell therapy A2B530 in patients with solid tumors.

Qian (Janie) Qin, MD, discusses the investigation and use of CAR T-cell therapy in patients with advanced clear cell renal cell carcinoma.

Mary “Nora” Disis, MD, discusses the rationale for investigating the efficacy and optimal delivery of PRGN-3005 autologous UltraCAR T cells in patients with advanced stage platinum-resistant ovarian cancer.

J. Randolph (Randy) Hecht, MD, discusses the observational BASECAMP-1 study and the investigation of HLA-A*02 as a target for the novel CAR T-cell therapy A2B530 in the phase 1/2 EVEREST-1 study, which will investigate A2B530 in patients with solid tumors.

J. Randolph (Randy) Hecht, MD, discusses barriers to treatment with CAR T-cell therapy in patients with solid tumors, highlighting various efforts that investigators are spearheading to address these unmet needs.

Ajai Chari, MD, discusses selecting between CAR T-cell therapies and bispecific antibodies in multiple myeloma, expands on the factors that can help inform these decisions, and highlights the need for additional data to help inform sequencing and potential combinations for these therapies.

The FDA has granted orphan drug designation to the next generation BCMA-directed CAR T-cell therapy NXC-201 for the treatment of patients with amyloid light chain amyloidosis.

Ajai Chari, MD, discusses the evolving role of bispecific antibodies and CAR T-cell therapies, such as ciltacabtagene autoleucel, in the treatment of patients with multiple myeloma.

Loretta J. Nastoupil, MD, discusses the rationale for investigating the use of lisocabtagene maraleucel in patients with relapsed/refractory follicular lymphoma.

Ajai Chari, MD, discusses the use of the CAR T-cell therapies idecabtagene vicleucel and ciltacabtagene autoleucel in the treatment of patients with multiple myeloma.

Patient preferences should be considered when selecting the optimal treatment regimen for patients with relapsed/refractory follicular lymphoma, as both CD19-directed CAR T-cell therapies and CD20-targeted bispecific antibodies can be efficacious in this population, according to a presentation by Caron A. Jacobson, MD, MMSc, at the 2023 SOHO Annual Meeting.