Systems and methods for distributing cell therapies
AssigneeAtara Biotherapeutics, Inc.
InventorDerrell D. Porter
Life of this patent
Estimating the term…
Abstract
The disclosure relates to delivery systems, and corresponding methods, for selecting and delivering an allogeneic T-cell line for administration to a patient, e.g., according to the HLA profile of the patient's somatic or diseased cells.
Claims134
An allogeneic T-cell therapy delivery system for selecting and delivering an allogeneic T-cell line for administration to a patient in need of allogeneic T-cell therapy, comprising:
- a product repository, the product repository comprising a plurality of samples comprising antigen-specific Cytotoxic T-Lymphocytes (CTLs), the CTLs of each sample having a known Human Leukocyte Antigen (HLA) profile and a known HLA restriction for said antigen;
- a communication channel, the communication channel receiving patient-characteristic data, including patient identification information and the HLA profile of the patient's somatic or diseased cells and, optionally, a physician assent to treatment of the patient with the allogeneic T-cell therapy;
- an allogeneic T-cell match generator, wherein the allogeneic T-cell match generator:
- determines an ordered set of cell lines from the product repository, the ordered set of cell lines prioritized at least according to a pre-determined match level between the HLA profile of the patient's somatic or diseased cells and HLA profiles and known restriction(s) of cell lines in the product repository;
- a registration module, the registration module receiving and registering the first cell line for administering to the patient;
- and
- a shipping module, the shipping module coordinating transport of the first cell line for administration to the patient.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the registration module receives and registers the physician assent to treatment of the patient.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line of the ordered set of cell lines is communicated to the patient's physician for approval prior to transport of the first cell line.
The allogeneic T-cell therapy delivery system of any preceding claim, further comprising a source repository, the source repository including donor peripheral blood mononuclear cells.
The allogeneic T-cell therapy delivery system of any preceding claim, further comprising a T-cell target activation module, wherein the T-cell target activation module:
- activates T-cells by contacting T-cells with an antigen of interest to generate antigen-specific CTLs;
- and
- populates the product repository with the antigen-specific CTLs.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the system confirms current availability of the first cell line of the ordered set of cell lines in the product repository prior to communicating or shipping the first cell line to the patient's physician.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is shipped to the physician within approximately 7 days after receiving the physician assent to treatment and/or the patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is shipped to the physician within approximately 6 days after receiving the physician assent to treatment and/or the patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is shipped to the physician within approximately 5 days after receiving the physician assent to treatment and/or the patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is shipped to the physician within approximately 4 days after receiving the physician assent to treatment and/or patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is shipped to the physician within approximately 3 days after receiving the physician assent to treatment and/or patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is administered to the patient within approximately 7 days after receiving the physician assent to treatment and/or patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is administered to the patient within approximately 6 days after receiving the physician assent to treatment and/or patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is administered to the patient within approximately 5 days after receiving the physician assent to treatment and/or patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is administered to the patient within approximately 4 days after receiving the physician assent to treatment and/or patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the first cell line is administered to the patient within approximately 3 days after receiving the physician assent to treatment and/or patient characteristic data.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein shipment to the physician, and/or administration to the patient, of the first cell line includes a first dose of the first cell line.
The allogeneic T-cell therapy delivery system of any preceding claim, further comprising a feedback module, the feedback module receiving information representative of the effect of administering the first cell line to the patient.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the allogeneic T-cell match generator determines an ordered set of up to four prioritized cell lines.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the ordered set of cell lines from the product repository consists of a single cell line.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the product repository is maintained at approximately −190° C. to −200° C.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the cell line(s) is maintained at approximately −190° C. to −200° C. during transport to the physician.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the cell line(s) is maintained at or below approximately −150° C. during transport to the physician.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the product repository is sorted by donor source.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the product repository is sorted by donor source HLA type.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the CTLs in the product repository are stored in single-use vials.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the patient-characteristic data includes transplant history, high resolution HLA data, and/or weight.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein patient-characteristic data includes an HLA profile of cells from a transplanted organ.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein patient characteristic data includes an HLA profile of transplanted allogeneic hematopoietic cells.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the system is configured for implementation with patients at risk, or exhibiting symptoms, of Post-Transplant Lymphoproliferative Disorder (PTLD).
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the system is configured for implementation with patients at risk, or exhibiting symptoms, of EBV-associated Post-Transplant Lymphoproliferative Disorder (PTLD).
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the system is configured for implementation with patients at risk, or exhibiting symptoms, of multiple sclerosis.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the system is configured for implementation with patients at risk, or exhibiting symptoms, of Cytomegalovirus infection.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the system is configured for implementation with patients at risk, or exhibiting symptoms, of leukemia or solid tumor cancers.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the antigen is a viral antigen.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein antigen-specific CTLs of the product repository meet a threshold for reactivity against cells expressing the antigen.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein said diseased cells are tumor cells.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein the product repository lacks CTLs having a predetermined HLA characteristic.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein CTLs of the product repository are free of pathogenic contaminants.
The allogeneic T-cell therapy delivery system of any preceding claim, further including a temperature sensor to monitor the temperature of the cell line(s) throughout transport of the cell line(s).
The allogeneic T-cell therapy delivery system of any preceding claim, further comprising a payment module, the payment module initiating payment for the cell line(s) upon receipt of the shipment by the physician.
The allogeneic T-cell therapy delivery system of any preceding claim, wherein an order of the first cell line includes shipment of three separate cycles of the first cell line to the physician.
A method of providing a cell therapy to a patient in need of such therapy comprising:
- providing a product repository comprising a plurality of samples comprising antigen-specific Cytotoxic T-Lymphocytes (CTLs), the CTLs of each sample having a known Human Leukocyte Antigen (HLA) profile and a known HLA restriction for said antigen;
- receiving patient-characteristic data, including patient identification information and an HLA profile of the patient's somatic or diseased cells;
- generating an allogeneic T-cell match selection, wherein generating includes:
- determining an ordered set of cell lines from the product repository, the ordered set of cell lines prioritized at least according to a pre-determined match level between the HLA profile of the patient's somatic or diseased cells and HLA profiles and known restriction(s) of cell lines in the product repository;
- optionally, receiving a physician assent to treatment of the patient with the cell therapy;
- and
- transporting the first cell line for administration to the patient.
Dependencies are inferred from the claim text.