Breakthrough Tumor Flare Management for Immunotherapy

Introduction

This innovative tumor flare management technology provides an essential method for controlling and mitigating the adverse effects associated with adoptive immunotherapy, a promising treatment approach for various cancers. By addressing the risk of tumor flare—an immune response that can cause temporary tumor growth and increased symptoms—this technology enables patients to experience the benefits of immunotherapy with reduced discomfort and complications. For companies in oncology, immunotherapy, and pharmaceuticals, this technology represents a critical asset, enhancing patient outcomes and expanding access to transformative cancer treatments.

The Challenge: Managing Tumor Flare in Immunotherapy

Tumor flare is a common complication in adoptive immunotherapy, particularly when treating patients with aggressive or advanced cancers. This response, triggered by an immune system attack on tumor cells, can lead to temporary tumor swelling, inflammation, and increased pain, causing distress and posing potential health risks for patients. Managing this response is crucial for healthcare providers, as it impacts treatment continuity, patient comfort, and the overall success of immunotherapy. Without effective management tools, tumor flare can undermine patient confidence and the potential of immunotherapy as a safe cancer treatment option.

Precise Tumor Flare Control for Optimal Patient Care

This tumor flare management method provides a structured approach to control and mitigate immune responses associated with adoptive immunotherapy. By incorporating specific interventions that regulate the immune response and prevent excessive inflammation, this technology minimizes the severity of tumor flare, allowing patients to continue their therapy with greater comfort and fewer interruptions. The protocol is designed to balance immune activity, ensuring that patients receive effective cancer treatment while minimizing the side effects associated with rapid tumor response. This focus on patient-centered care supports both short-term comfort and long-term therapeutic success.

Key Benefits for Oncology and Immunotherapy Providers

For pharmaceutical companies and immunotherapy providers, this technology offers a vital solution to enhance the patient experience during cancer treatment. It enables healthcare providers to implement a safer, more predictable approach to adoptive immunotherapy, increasing the therapy’s accessibility for a broader patient population. Oncology centers and immunotherapy facilities can incorporate this tumor flare management technology into their care protocols, improving treatment adherence and patient satisfaction. Its emphasis on comfort and safety aligns with the trend toward personalized medicine, making it a valuable addition to advanced cancer care practices.

Invest in Safer, Patient-Centered Cancer Treatments

Licensing this tumor flare management technology positions your company as a leader in patient-focused cancer care. By offering a sophisticated, effective solution for managing tumor flare, your business can support the future of immunotherapy and help more patients access innovative treatments with confidence. This technology is an essential investment for companies committed to improving patient outcomes, advancing immunotherapy, and supporting holistic, compassionate cancer treatment approaches.

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Abstract
Claims

Provided herein are methods of treating a solid malignant tumor using antigen-specific T cells and methods of managing tumor flare in treatment of a solid malignant tumor using antigen-specific T cells. The methods provided herein improve the safety of treatment by informing the patient about the potential risks for tumor flare, telling the patient to contact his or her physician if tumor swelling occurs, counseling a patient with Waldeyer’s ring lymphadenopathy to contact his or her physician if shortness of breath or stridor occurs, or grading and managing tumor flare developed in the patient.

What is claimed is:

1. A method of treating a solid malignant tumor in a human patient comprising the following steps in the order stated: (a) administering to the human patient a population of human cells comprising antigen-specific T cells that are specific for one or more antigens of the solid malignant tumor, said antigen-specific T cells having been generated by ex vivo sensitizing human T cells to the one or more antigens, wherein the antigen-specific T cells are not genetically engineered to be specific for the one or more antigens, wherein the population of human cells contains at least 70% T cells, and wherein the solid malignant tumor is a lymphoma; (b) grading tumor flare in the human patient as Grade 2, 3, or 4 according to the Evaluation column in the following Table, wherein the tumor flare is a clinical reaction to the administration of the population of human cells that is manifested as swelling of the tumor; and (c) managing tumor flare in the human patient according to the Intervention column in the following Table:

Tumor Flare Severity Evaluation Intervention Grade 2 Symptomatic; medical Medical treatment intervention indicated Grade 3 Stridor, respiratory Hospitalization with distress; hospitalization monitoring as appropriate indicated for the anatomic tumor site Grade 4 Life-threatening airway Intubation to protect the compromise; urgent airway if appropriate; other intervention indicated intervention according to the anatomic tumor site.

2. The method of claim 1, wherein after said administering the human patient develops tumor flare that is Grade 2 tumor flare; and the method comprises treating the tumor flare medically.

3. The method of claim 2, wherein the step of treating the tumor flare medically comprises providing one or more pain medications to the human patient.

4. The method of claim 3, wherein the one or more pain medications comprise a nonsteroidal anti-inflammatory drug (NSAID).

5. The method of claim 1, wherein after said administering the human patient develops tumor flare that is Grade 3 tumor flare; and the method comprises hospitalizing the human patient and monitoring the human patient as appropriate for the anatomic tumor site.

6. The method of claim 1, wherein after said administering the human patient develops tumor flare that is Grade 4 tumor flare; and the method comprises intubating the human patient to protect the airway or performing another intervention according to the anatomic tumor site.

7. In a method of treating a solid malignant tumor in a human patient that comprises administering to the human patient a population of human cells comprising antigen-specific T cells that are specific for one or more antigens of the solid malignant tumor, said antigen-specific T cells having been generated by ex vivo sensitizing human T cells to the one or more antigens, wherein the antigen-specific T cells are not genetically engineered to be specific for the one or more antigens, wherein the population of human cells contains at least 70% T cells, and wherein the solid malignant tumor is a lymphoma, wherein the improvement comprises: (a) grading tumor flare in the human patient as Grade 2, 3, or 4 according to the Evaluation column in the following Table, wherein the tumor flare is a clinical reaction to the administration of the population of human cells that is manifested as swelling of the tumor; and (b) managing tumor flare in the human patient according to the Intervention column in the following Table:

8. A method of treating a solid malignant tumor in a human patient comprising: (a) administering to the human patient a population of human cells comprising antigen-specific T cells that are specific for one or more antigens of the solid malignant tumor, said antigen-specific T cells having been generated by ex vivo sensitizing human T cells to the one or more antigens, wherein the antigen-specific T cells are not genetically engineered to be specific for the one or more antigens, wherein the population of human cells contains at least 70% T cells, and wherein the solid malignant tumor is a lymphoma; (b) monitoring the human patient for an indication of tumor flare, wherein the tumor flare is a clinical reaction to the administration of the population of human cells that is manifested as swelling of the tumor; (c) grading tumor flare in the human patient as Grade 2, 3, or 4 according to the Evaluation column in the following Table; and (d) managing tumor flare in the human patient according to the Intervention column in the following Table:

9. The method of claim 8, wherein the administering step is by bolus intravenous infusion.

10. The method of claim 8, which further comprises stopping treatment of the human patient with the population of human cells because the human patient has developed tumor flare that is life-threatening or deemed an excessive risk by the treating physician.

11. The method of claim 8, wherein the lymphoma is diffuse large B-cell lymphoma (DLBCL).

12. The method of claim 8, wherein the lymphoma is plasmablastic lymphoma (PBL).

13. The method of claim 8, wherein the solid malignant tumor is positive for Epstein-Barr virus (EBV) and the one or more antigens are one or more antigens of EBV.

14. The method of claim 8, wherein the anatomic site of the solid malignant tumor is inside the lymph nodes.

15. The method of claim 14, wherein the anatomic site of the solid malignant tumor is inside the neck lymph nodes.

16. The method of claim 8, wherein the anatomic site of the solid malignant tumor is within the head and neck region.

17. The method of claim 16, wherein the anatomic site of the solid malignant tumor is within the neck.

18. The method of claim 8, wherein the population of human cells comprising antigen-specific T cells is derived from a human donor that is allogeneic to the human patient.

19. The method of claim 8, wherein after said administering the human patient develops tumor flare that is Grade 2 tumor flare, wherein the method comprises treating the tumor flare medically, wherein the step of treating the tumor flare medically comprises providing one or more pain medications to the human patient, and wherein the one or more pain medications comprise an NSAID.

20. In a method of treating a solid malignant tumor in a human patient that comprises administering to the human patient a population of human cells comprising antigen-specific T cells that are specific for one or more antigens of the solid malignant tumor, said antigen-specific T cells having been generated by ex vivo sensitizing human T cells to the one or more antigens, wherein the antigen-specific T cells are not genetically engineered to be specific for the one or more antigens, wherein the population of human cells contains at least 70% T cells, and wherein the solid malignant tumor is a lymphoma, wherein the improvement comprises: (a) monitoring the human patient for an indication of tumor flare, wherein the tumor flare is a clinical reaction to the administration of the population of human cells that is manifested as swelling of the tumor; (b) grading tumor flare in the human patient as Grade 2, 3, or 4 according to the Evaluation column in the following Table; and (c) managing tumor flare in the human patient according to the Intervention column in the following Table:

21. A method of treating a solid malignant tumor in a human patient comprising: (a) administering to the human patient a population of human cells comprising antigen-specific T cells that are specific for one or more antigens of the solid malignant tumor, said antigen-specific T cells having been generated by ex vivo sensitizing human T cells to the one or more antigens, wherein the antigen-specific T cells are not genetically engineered to be specific for the one or more antigens, wherein the population of human cells contains at least 70% T cells, and wherein the solid malignant tumor is a lymphoma; (b) monitoring the human patient for an indication of tumor flare, wherein the tumor flare is a clinical reaction to the administration of the population of human cells that is manifested as swelling of the tumor; (c) stopping treatment of the human patient with the population of human cells because the human patient has developed tumor flare that is life-threatening or deemed an excessive risk by the treating physician; and (d) re-initiating treatment of the human patient with the population of human cells when the tumor flare subsides or decreases after stopping treatment.

22. The method of claim 21, wherein the solid malignant tumor is positive for EBV and the one or more antigens are one or more antigens of EBV.

23. The method of claim 21, wherein the lymphoma is DLBCL.

24. The method of claim 21, wherein the lymphoma is PBL.

25. In a method of treating a solid malignant tumor in a human patient that comprises administering to the human patient a population of human cells comprising antigen-specific T cells that are specific for one or more antigens of the solid malignant tumor, said antigen-specific T cells having been generated by ex vivo sensitizing human T cells to the one or more antigens, wherein the antigen-specific T cells are not genetically engineered to be specific for the one or more antigens, wherein the population of human cells contains at least 70% T cells, and wherein the solid malignant tumor is a lymphoma, wherein the improvement comprises: (a) monitoring the human patient for an indication of tumor flare, wherein the tumor flare is a clinical reaction to the administration of the population of human cells that is manifested as swelling of the tumor; (b) stopping treatment of the human patient with the population of human cells because the human patient has developed tumor flare that is life-threatening or deemed an excessive risk by the treating physician; and (c) re-initiating treatment of the human patient with the population of human cells when the tumor flare subsides or decreases after stopping treatment.

Title

Methods of managing tumor flare in adoptive immunotherapy

Inventor(s)

Robert Baiocchi

Assignee(s)

Atara Biotherapeutics Inc

Patent #

11925663

Patent Date

March 12, 2024