What side effects are associated with this type of intervention?

Common treatments for soft tissue sarcoma that involve genetically modified T cells and IL-2, such as CAR-T cell therapies and other immunotherapies, often have side effects including cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Neurologic events are also common, presenting as confusion, seizures, or severe headaches. Other side effects may include fatigue, infections due to immunosuppression, and organ toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for soft tissue sarcoma, though specific approvals for genetically modified T-cell therapies like attIL2-T cell therapy are not detailed in the provided context. However, immunotherapy approaches, including the use of immune checkpoint inhibitors such as pembrolizumab and nivolumab, have shown promise in treating various sarcoma subtypes. These therapies work by enhancing the body's immune response against cancer cells, similar to the mechanism of attIL2-T cell therapy, which uses genetically modified T cells enhanced by IL-2 to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to attIL2-T cell therapy for Soft Tissue Sarcoma patients include: 1) Regorafenib, which has shown improved progression-free survival (PFS) in nonadipocytic STS subtypes; 2) Bevacizumab, particularly in combination with temozolomide for highly vascular tumors like angiosarcoma; and 3) Masitinib, a tyrosine kinase inhibitor that has demonstrated a 27% slowing in the rate of functional decline in ALS, suggesting potential neuroprotective benefits that could be explored in STS. These alternatives are in various stages of clinical evaluation and may offer new avenues for treatment in 2024.

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CAR T-cell Therapy

attIL12 T-Cell Therapy for Sarcoma

Phase 1

Recruiting

Led By John Livingston, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The trial is testing attIL2-T cell therapy combined with Cyclophosphamide in patients with soft tissue or bone sarcomas. The goal is to determine a safe dosage that can control the disease. Participants will receive T-cells designed to target tumor cells directly.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs; symptoms from cyclophosphamide like nausea and low blood counts; increased risk of infection due to weakened immune defenses; and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To examine the incidence of adverse events.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Osteosarcoma Dose ExpansionExperimental Treatment2 Interventions

Participants will receive attIL2-T cell therapy at the recommended dose that was found in Phase 1.

Group II: Part A: Dose Findings (MTD)Experimental Treatment2 Interventions

The dose of attIL2-T cell therapy the participants will receive will depend on when the participants joined this study. The first group of participants will receive the lowest dose level of attIL2-T cell therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Soft Tissue Sarcoma (STS) include chemotherapy, targeted therapies, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, while targeted therapies inhibit specific molecules involved in tumor growth and progression. Immunotherapy, particularly genetically modified T cells like those in attIL2-T cell therapy, involves engineering T cells to specifically target and kill cancer cells. These T cells are often enhanced with cytokines like IL-2 to boost the immune response. This approach is significant for STS patients as it offers a more precise attack on cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional treatments.