A Phase I Feasibility and Safety Study of Fluorescein-Specific (FITC-E2) CAR T Cells in Combination with Parenterally Administered Folate-Fluorescein (UB-TT170) for Osteogenic Sarcoma

Last updated: November 5, 2024
Sponsor: Seattle Children's Hospital
Overall Status: Active - Not Recruiting

Phase

1

Condition

Sarcoma

Osteosarcoma

Treatment

UB_TT170

SCRI-E2CAR_EGFRtv1

Clinical Study ID

NCT05312411
ENLIGHTen-01
  • Ages 15-30
  • All Genders

Study Summary

The purpose of this study is to see if a new treatment could help patients who have osteosarcoma that does not go away with treatment (is refractory) or comes back after treatment (is recurrent).This study is testing a combination of study therapies, UB-TT170 and genetically modified chimeric antigen receptor T lymphocyte (CAR T) cells, which work together in a way that is different from chemotherapy.

In this study, researchers will take some of your blood and remove the T cells in a process called "apheresis". Then the T cells are taken to a lab and changed to CAR T cells that recognize the flags from UB-TT170. Once researchers think they have grown enough CAR T cells, called antiFL(FITC-E2) CAR T cells, to fight your cancer, you may get some chemotherapy to make room in your body for the new cells and then have those cells put back in your body.

A few days after the you get your CAR T cell infusion you will start to get infusions of UB-TT170, with the dose slowly increasing for the first few infusions until you have reached a maximum dose that you will get on a regular schedule. The UB-TT170 will attach to your tumor cells and flag them so that they attract the CAR T cells. When the CAR T cells see the labeled tumor cells they can kill the tumor cells.

The active part of the study lasts about 8 months, and if you get the CAR T cell infusion you will be in long-term follow-up for 15 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Refractory or recurrent/progressive osteosarcoma that has failed first line therapyfor Osteosarcoma per NCCN or upfront Children's Oncology Group clinical trial and isnot amenable to surgical resection (must meet one of the following):

  1. New site of measurable disease by radiographic imaging or histologicconfirmation

  2. New site of evaluable disease by radiographic imaging (including FDG-PET) orhistologic 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 existinglesion(s) (previously irradiated lesions may be included)

  4. Persistent measurable disease or FDG-PET avid bone metastasis that has failedto achieve complete remission to upfront conventional therapy (surgery,radiotherapy and/or chemotherapy)

  • Able to tolerate apheresis, including placement of temporary apheresis catheter, ifnecessary, 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-tumorantibody therapy, genetically modified cell therapy, and, if no apheresis productavailable, corticosteroid therapy (excluding physiologic replacement), discontinuedwithin 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 effectivecontraception through 12 months following final stud drug infusion

Exclusion

Exclusion Criteria:

  • Active malignancy other than primary malignant solid tumor diagnosis (CNSintracranial 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 yearfollow up

  • Presence of any condition that, in the opinion of the investigator, would prohibitthe subject from undergoing treatment under this protocol.

Study Design

Total Participants: 21
Treatment Group(s): 2
Primary Treatment: UB_TT170
Phase: 1
Study Start date:
May 20, 2022
Estimated Completion Date:
April 30, 2040

Connect with a study center

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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