INTRODUCTION:

Immune Effector and T-cell directed therapy, such as CAR T-cell therapy and T-cell engager treatments such as Bi-Specific antibody treatments, has revolutionized the treatment of hematologic malignancies. CAR T-cell treatment has its own limitations, and it often requires cumbersome manufacturing processes and is associated with high costs and appropriate infrastructure. Off the shelf therapies such bi-specific antibodies have been approved for the treatment of acute lymphoblastic leukemia, multiple myeloma, follicular lymphoma, and diffuse large B-cell lymphoma in the United States (US). Additionally other bi-specific antibodies are being developed for hematologic malignancies and other diseases. However, despite FDA approval of these agents, most patients being treated in the community do not have access to these agents due to concerns about potential adverse reactions and the required infrastructure. Additionally, most of the study clinical sites for these therapies have included few community oncology centers thus disadvantaging them from the ability to set up pre-approval infrastructure and subsequent implementation of immune effector therapies at community oncology centers.

Most patients with hematologic malignancies in the US are treated at community oncology practices, yet currently available therapies are delivered at academic centers with resultant non-diverse patients currently been offered these therapies and further worsening existing disparities in cancer care, particularly for these lifesaving therapies and exacerbating the nonavailability of clinical trial or real-world data of immune effector therapies for diverse populations.

The desire to provide modern cellular therapies to patients in the community, where most cancer patients in the US are treated, is the reason we created a NETWORK of community providers who are interested in establishing the infrastructure for cellular therapies and delivering such services to their patients. Cellular therapies in this definition would include bi-specific antibodies, CAR-T therapies and other immunotherapies directed towards T-cells or malignant cells defined as appropriate for inclusion by the organization.

We believe the immediate needs of community oncology are to establish cellular therapies and immunotherapies focusing on the most pressing initial need for protocols and SOP’s for managing bi-specific antibody-based therapies and subsequently creating an organization to promote the establishment of the infrastructure for the safe and effective administration of immune effector therapies, and the participation of good quality clinical trials with a focus on participant diversity.