What is the mechanism of action of this treatment?

Traditional treatments for osteosarcoma typically include surgery, chemotherapy, and radiation therapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while surgery aims to remove the tumor physically. Radiation therapy uses high-energy rays to destroy cancer cells. The novel treatment involving UB-TT170 and CAR T cells represents a significant advancement. UB-TT170 flags the tumor cells, making them recognizable to the genetically modified CAR T cells, which then target and kill these flagged cells. This targeted approach can potentially improve treatment efficacy and reduce side effects compared to conventional therapies, offering new hope for patients with refractory or recurrent osteosarcoma.

What side effects are associated with this type of intervention?

The most common treatments for osteosarcoma, particularly those involving CAR T cell therapies like the UB-TT170 and CAR T cell combination, can cause several side effects. CAR T cell therapies may lead to cytokine release syndrome (CRS), presenting with fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and breathing difficulties. Neurologic toxicities, such as confusion, seizures, and encephalopathy, are also common. Chemotherapy, often used alongside CAR T cell therapies, can result in nausea, vomiting, hair loss, fatigue, increased infection risk, and anemia due to its effects on rapidly dividing cells.

What other types of research exist?

Promising novel alternatives for osteosarcoma treatment in 2024 include immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) which enhance the immune system's ability to target cancer cells, and targeted therapies such as tyrosine kinase inhibitors (e.g., sorafenib, regorafenib) that inhibit specific pathways involved in tumor growth. Additionally, advancements in oncolytic virus therapy and personalized cancer vaccines are emerging as potential options.

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CAR T-cell Therapy

FITC-E2 CAR T Cells + Folate-Fluorescein for Osteosarcoma

Q: What prior FDA approvals exist?

Currently, there are no FDA-approved treatments for osteosarcoma that specifically use a mechanism similar to the UB-TT170 and CAR T cell therapy, which involves flagging tumor cells for immune cell recognition and destruction. Traditional treatments for osteosarcoma typically include surgery, chemotherapy, and radiation therapy. However, investigational therapies like the one in the UB-TT170 and CAR T cell trial are being explored to improve outcomes for patients with refractory or recurrent osteosarcoma.

Phase 1

Waitlist Available

Led By Catherine Albert, MD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Able to tolerate apheresis, including placement of temporary apheresis catheter, if necessary, or already has an apheresis product available for use in manufacturing

Refractory or recurrent/progressive osteosarcoma that has failed first line therapy for Osteosarcoma per NCCN or upfront Children's Oncology Group clinical trial and is not amenable to surgical resection

Must not have

Active malignancy other than primary malignant solid tumor diagnosis (CNS intracranial metastases are allowed)

Ongoing, symptomatic CNS pathology requiring medical intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for patients with hard-to-treat or recurring osteosarcoma. It uses a special drug and modified immune cells to target and kill cancer cells. The patient's own immune cells are changed in a lab to better recognize cancer, and a drug helps these cells find and destroy the cancer.

Who is the study for?

This trial is for patients with osteosarcoma that's resistant to treatment or has returned. Participants must have a new site of disease confirmed by imaging, be able to undergo apheresis, and have a life expectancy of at least 8 weeks. They should not have HIV or hepatitis, agree to use contraception if applicable, and have good organ function. Exclusions include active severe infections, other cancers, primary immunodeficiency syndrome, pregnancy/breastfeeding, and any condition preventing protocol adherence.

What is being tested?

The study tests UB-TT170 combined with modified CAR T cells against osteosarcoma. Patients' T cells are collected and engineered in the lab to target cancer flagged by UB-TT170. After chemotherapy preparation, these CAR T cells are infused back into the patient followed by regular doses of UB-TT170 to mark cancer cells for destruction by CAR T cells.

What are the potential side effects?

Potential side effects may include reactions from cell infusion like fever or fatigue; complications from chemotherapy such as nausea; immune responses where the body attacks its own tissues; increased risk of infection due to weakened immunity; and possible long-term effects which will be monitored over 15 years.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can undergo apheresis or already have an apheresis product ready for use.

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My osteosarcoma has not responded to the first treatment and cannot be removed with surgery.

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My tumor has grown by more than 20% but not more than 5mm in its largest size.

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I can do most activities but need help with some.

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My cancer did not fully respond to initial treatments like surgery or chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no active cancer other than my primary solid tumor.

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I need treatment for a brain or spinal cord problem that's causing symptoms.

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I am currently undergoing external beam radiotherapy.

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I am currently fighting a severe infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events associated with ex-vivo expanded autologous T cells genetically modified to express an antiFL(FITC-E2) CAR administered with UB-TT170 will be assessed

Secondary study objectives

Ability to manufacture antiFL(FITC-E2) CAR cells

Evaluate the pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: UB-TT170 following SCRI-E2CAR_EGFrtv1Experimental Treatment2 Interventions

Following CAR T cell administration, subjects will receive a first Course of 3 escalating doses of UB-TT170 over 2 weeks followed by fixed weekly dosing for 2 weeks. If eligible, subjects may proceed to Courses 2 - 4 consisting of 7 weekly doses of UB-TT170.

0 / 9Eligibility criteria met

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

Traditional treatments for osteosarcoma typically include surgery, chemotherapy, and radiation therapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while surgery aims to remove the tumor physically. Radiation therapy uses high-energy rays to destroy cancer cells. The novel treatment involving UB-TT170 and CAR T cells represents a significant advancement. UB-TT170 flags the tumor cells, making them recognizable to the genetically modified CAR T cells, which then target and kill these flagged cells. This targeted approach can potentially improve treatment efficacy and reduce side effects compared to conventional therapies, offering new hope for patients with refractory or recurrent osteosarcoma.