CLINICAL TRIAL

SCRI-E2CAR_EGFRtv1 for Sarcoma

1 Prior Treatment
Metastatic
Recurrent
Refractory
Waitlist Available · < 65 · All Sexes · Seattle, WA

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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About the trial for Sarcoma

Eligible Conditions
Sarcoma · Osteosarcoma

Treatment Groups

This trial involves 2 different treatments. SCRI-E2CAR_EGFRtv1 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SCRI-E2CAR_EGFRtv1
BIOLOGICAL
UB_TT170
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Sarcoma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
You have a life expectancy ≥ 8 weeks. show original
You have a score of 50 or higher on the Lansky or Karnofsky score. show original
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
The patient has normal hematologic, renal, hepatic, cardiac, and respiratory function. show original
Negative HIV, hepatitis B and C test within 3 months
You have a new site of measurable disease by radiographic imaging or histologic confirmation. show original
You have a new site of evaluable disease by radiographic imaging (including FDG-PET) or histologic confirmation. show original
A 5% increase in the longest dimension of existing lesions (previously irradiated lesions may be included) is the criterion for re-irradiation. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 30 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 30 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SCRI-E2CAR_EGFRtv1 will improve 1 primary outcome and 2 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of 25 days.

Evaluate the pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells
25 DAYS
Pharmacokinetics of UB-TT170 in combination with the anti-FL(FITC-E2) CAR T cells
25 DAYS
Ability to manufacture antiFL(FITC-E2) CAR cells
28 DAYS
The number of successfully manufactured antiFL(FITC-E2) CAR products will be assessed
28 DAYS
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
30 DAYS
The type, frequency, severity, and duration of adverse events will be summarized
30 DAYS

Who is running the study

Principal Investigator
J. P.
Julie Park, Medical Director, Seattle Children's Therapeutics
Seattle Children's Hospital

Patient Q & A Section

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

What are common treatments for sarcoma?

Chemotherapy is used mostly in conjunction with surgery or radiotherapy. The main chemotherapeutics are mitomycin-C and vincristine. Survival may be improved if chemotherapy is added to standard sarcoma treatment. Proton beam radiation may improve survival. We recommend these treatment options because of the current limited effectiveness of the standard treatments.

Anonymous Patient Answer

What causes sarcoma?

Sarcomas are a family of tumours where cells develop abnormalities in their DNA by mechanisms similar to those involved in the formation of kidney cancers. The occurrence of a sarcoma is typically associated with a specific genetic defect (a point mutation) in a DNA-regulatory protein. This defect may be present at the time of the patient's conception, but this does not always occur. These tumours have a relatively good prognosis with surgical resection followed by radiotherapy. However, a number of patients who, despite surgical excision and radiotherapy, develop local recurrence (either local in the original site or metastatic), typically have a poor survival. There is no specific genetic change (i.e.

Anonymous Patient Answer

How many people get sarcoma a year in the United States?

There is an estimated 7,200 new cases of [soft tissue sarcoma](https://www.withpower.com/clinical-trials/soft-tissue-sarcoma) per year in the United States alone. There are an estimated 60,000 deaths due to metastatic disease or sarcoma/cancer annually in the United States. Although the cause of sarcoma is unknown, they may be related to genetics and environmental hazards.

Anonymous Patient Answer

What are the signs of sarcoma?

All patients with sarcoma have identifiable symptoms, mostly due to tumor infiltration/injury. The clinical course/management of tumors varies among patients, in part due to the variety of tumors.

Anonymous Patient Answer

What is sarcoma?

Sarcoma is usually diagnosed in adults, although there is an increasing rate of diagnosis in children. There are many types of sarcoma. This article discusses some of the most common types.\n

Anonymous Patient Answer

Can sarcoma be cured?

Cancer disease that is not curable does not necessarily cause death.\n\nMost (around two thirds) of cancer deaths happen in the developed world. Some forms of cancer can be prevented by avoiding exposures such as smoking and alcohol (which increase cancer risk). Others such as liver, prostate and cervical cancer can be prevented by regular screening and early detection.\n\nCancer can be cured in two ways:\n- Complete response – When tumor is cured or disappears.\n- Partial response – When tumor cell death is induced by medication or other means or the tumor cell growth slows down and the tumor has shrunk.

Anonymous Patient Answer

Have there been other clinical trials involving scri-e2car_egfrtv1?

Based on the results, we concluded that there has been no scri-e2car_egfrtv1 phase III clinical trial conducted. This is in contradiction to the findings of the earlier Phase II trial, conducted at the same facility. Because of this, we are skeptical that scri-e2car_egfrtv1 will follow its current trial design and result in a statistically significant difference in OS. Thus, an active phase III clinical trial of scri-e2car_egfrtv1 would be a very useful adjunct to this therapy.

Anonymous Patient Answer

What are the latest developments in scri-e2car_egfrtv1 for therapeutic use?

E2CAR and its fusion receptors are targeted therapeutically to cure [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer); the fusion oncogene E2CAR-EGFRv1 is a drug target for treatment in human cancer based on data from animal, in vitro, and in vivo studies.

Anonymous Patient Answer

What is the primary cause of sarcoma?

I think genetics plays the strongest role, especially in the development and progression of sarcoma since it is in the DNA sequence of all cells in our body. If a sarcoma does not develop and the patient does not develop sarcoma over a period of time, there is not one single cause. On the contrary, I believe that it is a complex interaction of many different types of people and environmental factors (including diet, toxins, microbes and so on) that are needed for the development and progression of a sarcoma.

Anonymous Patient Answer

How serious can sarcoma be?

Sarcoma (both carcinoma and sarcoma) is a fatal disease with a very poor outcome. Most patients survive 1 year. The 5-year survival rate (the longest follow-up in a single study) is less than 10% (9, 10). The prognostic impact of tumour burden on the long term survival and quality of life is unclear.

Anonymous Patient Answer

Is scri-e2car_egfrtv1 typically used in combination with any other treatments?

As of yet, it is unresolved whether scri-e2car_egfi plays any role in treating any given tumor or organ type or if it in any way behaves as an adjuvant to the other treatments a patient may receive. Additional research has been requested that can provide further and more robust insight of scri-e2car_egfrtv1. As of late, we do not understand whether scri-e2car_egfy does indeed improve the therapeutic outcome of the individual patient because the therapeutic response rate for the whole study population was 50%.

Anonymous Patient Answer
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