Engineered immune cells take aim at stubborn bone cancer
NCT ID NCT05312411
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a two-part treatment for osteosarcoma that has come back or not responded to standard care. First, a patient's own T cells are collected and genetically modified to become CAR T cells that can recognize a special flag. Then, after some chemotherapy, the CAR T cells are infused back, followed by doses of a molecule (UB-TT170) that attaches to tumor cells and flags them for destruction by the CAR T cells. The study involves 21 participants and focuses on safety and feasibility over about 8 months of active treatment, with long-term follow-up for 15 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genetically modified CAR T cells (antiFL(FITC-E2)) and a targeting molecule (UB-TT170)
- What this could lead to
- If it works, this could point toward a new treatment option for osteosarcoma that doesn't respond to standard therapy.
- What could go wrong
- This is a very early phase 1 trial with only 21 participants, so it's mainly testing safety and feasibility. The treatment may not shrink tumors, and there are risks from chemotherapy and the CAR T cells themselves.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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May 2040
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 to 30 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 meet one of the following): 1. New site of measurable disease by radiographic imaging or histologic confirmation 2. New site of evaluable disease by radiographic imaging (including FDG-PET) or histologic confirmation 3. Greater than 20% increase in at least one tumor dimension documented by CT/MRI, AND a maximum absolute increase of 5 mm in longest dimension of existing lesion(s) (previously irradiated lesions may be included) 4. Persistent measurable disease or FDG-PET avid bone metastasis that has failed to achieve complete remission to upfront conventional therapy (surgery, radiotherapy and/or chemotherapy) * Able to tolerate apheresis, including placement of temporary apheresis catheter, if necessary, or already has an apheresis product available for use in manufacturing * Life expectancy ≥ 8 weeks * Lansky or Karnofsky score ≥ 50 * Anti-cancer agents, radiotherapy, cytoxic chemotherapy, biologic therapy, anti-tumor antibody therapy, genetically modified cell therapy, and, if no apheresis product available, corticosteroid therapy (excluding physiologic replacement), discontinued within protocol specified wash-out period * Adequate hematologic, renal, hepatic, cardiac, and respiratory function. * Negative HIV, hepatitis B and C test within 3 months * If of child-bearing or fathering potential, willing to use highly effective contraception through 12 months following final stud drug infusion Exclusion Criteria: * Active malignancy other than primary malignant solid tumor diagnosis (CNS intracranial metastases are allowed) * Ongoing, symptomatic CNS pathology requiring medical intervention * Receiving external beam radiotherapy * Presence of active, severe infection * Primary immunodeficiency syndrome * Pregnant or breast feeding * Unwilling to provide consent/assent for study participation, including 15 year follow up * Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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Other studies related to the condition(s) this trial covers.
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