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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

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ClinicalTrials.gov Identifier: NCT05312411
Recruitment Status : Recruiting
First Posted : April 5, 2022
Last Update Posted : December 21, 2022
Sponsor:
Collaborator:
Umoja BioPharma, Inc.
Information provided by (Responsible Party):
Rebecca Gardner, Seattle Children's Hospital

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Osteosarcoma Biological: SCRI-E2CAR_EGFRtv1 Drug: UB_TT170 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-Ew) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma
Actual Study Start Date : May 20, 2022
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2040

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: UB-TT170 following SCRI-E2CAR_EGFrtv1
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.
 Biological: SCRI-E2CAR_EGFRtv1
Autologous CD4+ and CD8+ T cells that have been genetically modified to express antiFL(FITC-E2)

Drug: UB_TT170
Bispecific small molecule adapter formulated with phosphate buffered saline


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 30 days ]
    The type, frequency, severity, and duration of adverse events will be summarized


Secondary Outcome Measures :
  1. Ability to manufacture antiFL(FITC-E2) CAR cells [ Time Frame: 28 Days ]
    The number of successfully manufactured antiFL(FITC-E2) CAR products will be assessed

  2. Evaluate the pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells [ Time Frame: 25 days ]
    Pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05312411


Contacts
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Contact: Catherine Albert, MD 206-987-2106 immunotherapy@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Catherine Albert, MD    206-987-2106    immunotherapy@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Umoja BioPharma, Inc.
Investigators
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Principal Investigator: Catherine Albert, MD Seattle Children's Hospital
More Information
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Responsible Party: Rebecca Gardner, Medical Director, Seattle Children's Therapeutics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT05312411    
Other Study ID Numbers: ENLIGHTen-01
First Posted: April 5, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Gardner, Seattle Children's Hospital:
osteosarcoma
bone cancer
pediatric sarcoma
young adult sarcoma
Additional relevant MeSH terms:
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Sarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue