Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Umoja Biopharma
Conditions:
Osteosarcoma
Eligibility:
All Genders
15-30 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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):
- New site of measurable disease by radiographic imaging or histologic confirmation
- New site of evaluable disease by radiographic imaging (including FDG-PET) or histologic confirmation
- 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)
- 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
- 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.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2040
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05312411
Start Date
May 20 2022
End Date
May 1 2040
Last Update
November 20 2025
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105