FITC-E2 CAR T Cells + Folate-Fluorescein for Osteosarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for osteosarcoma, a type of bone cancer, particularly in cases unresponsive to existing treatments or recurring after treatment. Researchers are testing a combination of genetically modified immune cells, called CAR T cells (specifically, FITC-E2 CAR T Cells), and a new drug, UB-TT170, to determine if they can jointly target and destroy cancer cells. Participants may qualify if they have osteosarcoma that hasn’t improved with previous treatments and are willing to undergo a process to modify their immune cells. The active treatment period lasts about 8 months, with follow-ups extending up to 15 years. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires that certain medications, like anti-cancer agents, radiotherapy, chemotherapy, and some others, be stopped within a specific 'washout' period (time without taking certain medications) before participating. It's best to discuss your current medications with the trial team to see if they need to be paused.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatment under study, which includes special immune cells called SCRI-E2CAR_EGFRtv1 CAR T cells and a drug called UB-TT170, contains important safety information. In trials, patients with osteosarcoma received set amounts of these CAR T cells, followed by increasing amounts of UB-TT170. Some patients experienced changes in cytokine levels, which indicate how well the immune system functions.
These trials test safety and feasibility, checking if the treatment can be administered without major issues. The study remains in the early stages, focusing mainly on safety. Researchers are looking for side effects and are still collecting data. It's important to know that these treatments are experimental and not yet proven safe or effective for everyone.
For those considering joining the trial, it's helpful to understand that this is an early-stage study, concentrating on determining the treatment's safety for humans.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatment using FITC-E2 CAR T Cells combined with Folate-Fluorescein for osteosarcoma because it offers a new, targeted approach. Unlike traditional chemotherapy or surgery, which can have widespread effects on the body, this treatment uses CAR T cells, a type of immune cell engineered to specifically recognize and attack cancer cells. The addition of folate-fluorescein helps enhance the targeting process, potentially leading to more effective eradication of the tumor while minimizing damage to healthy tissues. This precision targeting could offer new hope for patients with osteosarcoma, a challenging cancer to treat with current options.
What evidence suggests that this trial's treatments could be effective for osteosarcoma?
Research has shown that CAR T cells can effectively destroy osteosarcoma cancer cells, suggesting they might be a promising targeted treatment for this type of cancer. In this trial, participants will receive CAR T cells followed by UB-TT170. This combination tags the cancer cells, making it easier for the modified T cells to attack them. Although osteosarcoma is difficult to treat, this method offers a new way to combat the cancer. Early studies have been encouraging, but researchers are still testing its effectiveness in people. More research is needed to confirm its effectiveness.23467
Who Is on the Research Team?
Catherine Albert, MD
Principal Investigator
Seattle Children's Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and CAR T Cell Manufacturing
Blood is drawn from participants to extract T cells, which are then modified in a lab to become CAR T cells.
Treatment
Participants receive chemotherapy followed by CAR T cell infusion and escalating doses of UB-TT170.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants who received CAR T cell infusion are monitored for long-term safety and outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- SCRI-E2CAR_EGFRtv1
- UB_TT170
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
Umoja Biopharma
Industry Sponsor
Umoja BioPharma, Inc.
Collaborator