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CAR T-cell Therapy

FITC-E2 CAR T Cells + Folate-Fluorescein for Osteosarcoma

Phase 1

Recruiting

Led By Catherine Albert, MD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to tolerate apheresis, including placement of temporary apheresis catheter, if necessary, or already has an apheresis product available for use in manufacturing

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is testing a new combination treatment for osteosarcoma that has not responded to other treatments or has returned after treatment.

Who is the study for?

This trial is for patients with osteosarcoma that's resistant to treatment or has returned. Participants must have a new site of disease confirmed by imaging, be able to undergo apheresis, and have a life expectancy of at least 8 weeks. They should not have HIV or hepatitis, agree to use contraception if applicable, and have good organ function. Exclusions include active severe infections, other cancers, primary immunodeficiency syndrome, pregnancy/breastfeeding, and any condition preventing protocol adherence.Check my eligibility

What is being tested?

The study tests UB-TT170 combined with modified CAR T cells against osteosarcoma. Patients' T cells are collected and engineered in the lab to target cancer flagged by UB-TT170. After chemotherapy preparation, these CAR T cells are infused back into the patient followed by regular doses of UB-TT170 to mark cancer cells for destruction by CAR T cells.See study design

What are the potential side effects?

Potential side effects may include reactions from cell infusion like fever or fatigue; complications from chemotherapy such as nausea; immune responses where the body attacks its own tissues; increased risk of infection due to weakened immunity; and possible long-term effects which will be monitored over 15 years.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can undergo apheresis or already have an apheresis product ready for use.

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My osteosarcoma has not responded to the first treatment and cannot be removed with surgery.

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My tumor has grown by more than 20% but not more than 5mm in its largest size.

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I can do most activities but need help with some.

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My cancer did not fully respond to initial treatments like surgery or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Ability to manufacture antiFL(FITC-E2) CAR cells

Evaluate the pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells

Trial Design

1Treatment groups

Experimental Treatment

Group I: UB-TT170 following SCRI-E2CAR_EGFrtv1Experimental Treatment2 Interventions

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,718 Total Patients Enrolled

2 Trials studying Osteosarcoma

112 Patients Enrolled for Osteosarcoma

Umoja BioPharma, Inc.UNKNOWN

Catherine Albert, MDPrincipal InvestigatorSeattle Children's Hospital

Media Library

SCRI-E2CAR_EGFRtv1 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05312411 — Phase 1

Osteosarcoma Research Study Groups: UB-TT170 following SCRI-E2CAR_EGFrtv1

Osteosarcoma Clinical Trial 2023: SCRI-E2CAR_EGFRtv1 Highlights & Side Effects. Trial Name: NCT05312411 — Phase 1

SCRI-E2CAR_EGFRtv1 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05312411 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks do people face when exposed to UB_TT170?

"Currently, there are limited clinical studies that validate the safety and efficacy of UB_TT170. Thus, our team assigned it a score of 1 on a scale from 1 to 3."

Answered by AI

Is there availability to join this clinical research study?

"Eligibility for this trial necessitates that recruits have osteosarcoma and are aged between 15 and 30. The total number of participants sought is approximately 21."

Answered by AI

Do the requirements for this clinical experiment extend to those aged 75 or over?

"The specified selection criteria for this clinical trial indicates that only participants aged 15 to 30 are qualified. In comparison, 200 studies target those under 18 and 389 focus on individuals over 65 years of age."

Answered by AI

What is the current size of the participant population for this trial?

"Affirmative. The information hosted on clinicaltrials.gov testifies that this particular medical trial, which was launched on May 20th 2022, is still recruiting patients. At the moment, 21 participants need to be sourced from 1 distinct health centre."

Answered by AI

Is there an ongoing opportunity to join this clinical research endeavor?

"Presently, the clinical trial is still recruiting participants. The original posting date was May 20th 2022 and it has been recently updated on November 28th 2022 according to information hosted on clinicaltrials.gov."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Colleen Annesley 2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05312411.

All > Osteosarcoma > Bone Cancer