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Engineered immune cells take aim at stubborn bone cancer

NCT ID NCT05312411

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

May 2040

An estimate. End dates often move.

Lead sponsor

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

15 to 30 years

Sex

Anyone

Healthy volunteers

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

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

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.