attIL12 T-Cell Therapy for Sarcoma
Trial Summary
What is the purpose of this trial?
This trial is testing a new treatment that uses specially modified immune cells combined with a drug to help fight advanced or hard-to-treat soft tissue and bone cancers. The goal is to see if this approach can safely control the disease in patients who have not responded well to other treatments.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment at the time of leukapheresis or attIL12 T cell infusion. Standard of care anti-cancer therapy is allowed after leukapheresis but before starting cyclophosphamide. Non-cancer-related medications like insulin for diabetes are acceptable.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment at the time of leukapheresis or attIL12 T cell infusion. You can continue using hormones for non-cancer-related conditions like insulin for diabetes.
What data supports the idea that attIL12 T-Cell Therapy for Sarcoma is an effective treatment?
The available research shows that while attIL12 T-Cell Therapy for Sarcoma is a promising approach, there is limited direct evidence of its effectiveness specifically for sarcoma. However, other similar T-cell therapies, like CAR-T cell therapy, have shown encouraging results in treating sarcomas by targeting specific antigens associated with the cancer. These therapies have been successful in other cancers, suggesting potential for sarcoma treatment. Additionally, the research on tumor-infiltrating lymphocytes (TILs) indicates that certain sarcoma subtypes can yield enough TILs for therapy, which may support the effectiveness of T-cell-based treatments like attIL12.12345
What data supports the effectiveness of the attIL12 T-Cell Therapy treatment for sarcoma?
Research shows that modified T-cell therapies, like CAR-T cell therapy, have shown promise in treating other cancers and are being explored for sarcomas. Additionally, therapies using tumor-infiltrating lymphocytes (TILs) have potential in sarcoma treatment, as certain sarcoma subtypes can yield enough TILs for therapy, suggesting a personalized approach could be effective.12345
What safety data is available for attIL12 T-Cell Therapy for Sarcoma?
The safety data for attIL12 T-Cell Therapy, which may be related to other engineered T-cell therapies like CAR-T and TCR-T cells, indicates that while these therapies show promise in treating cancer, they are associated with significant toxicities. These include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and on-target off-tumor effects. Preclinical studies in mice have shown no acute toxicity or immunotoxicity for TCRα-transduced T cells, suggesting a favorable safety profile. However, clinical trials have reported significant toxicity related to antigen expression on normal tissues. Efforts are ongoing to improve safety measures, such as the use of inducible safety switches, to mitigate these risks.678910
Is attIL12 T-Cell Therapy generally safe for humans?
Research on similar T-cell therapies shows that while they can be effective against cancer, they may also cause significant side effects like cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage). However, some studies have shown no obvious systemic side effects, indicating that safety can vary depending on the specific therapy and its application.678910
Is attIL12 T-Cell Therapy a promising treatment for sarcoma?
Yes, attIL12 T-Cell Therapy is a promising treatment for sarcoma. It is part of a new wave of immunotherapies that use the body's own immune cells to fight cancer. This approach has shown potential in increasing the effectiveness of treatment by targeting specific cancer cells, which could lead to better outcomes for patients with sarcoma.1351112
What makes attIL12 T-Cell Therapy unique for treating sarcoma?
attIL12 T-Cell Therapy is unique because it involves genetically modifying T-cells to express IL-12, a protein that boosts the immune response, directly on their surface, which may enhance their ability to target and destroy cancer cells in sarcoma. This approach is different from traditional treatments as it aims to harness and amplify the body's own immune system to fight the cancer more effectively.1351112
Research Team
John A Livingston, MD MS
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for people aged 12 and older with advanced or metastatic soft tissue or bone sarcoma, who have tried at least one systemic therapy unless none exist for their subtype. They must be in good physical condition (ECOG status of 0 or 1), not pregnant, willing to use contraception, and have proper organ function. Exclusions include active infections like hepatitis B/C, autoimmune diseases within the past two years, untreated brain metastases, recent major surgery, HIV/AIDS, other cancer treatments ongoing or a second active malignancy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive attIL12-T cell therapy in combination with cyclophosphamide to determine safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- attIL2-T cells
- Cyclophosphamide
attIL2-T cells is already approved in United States for the following indications:
- Advanced/Metastatic Soft Tissue Sarcoma
- Bone Sarcoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor