Is NCT07428993 recruiting in Memphis, TN?

Yes, NCT07428993 is currently recruiting participants at its Memphis, TN location. This pediatric osteosarcoma clinical trial is actively enrolling qualified participants.

How do I join the pediatric osteosarcoma clinical trial in Memphis?

To join this clinical trial in Memphis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Memphis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pediatric Osteosarcoma Clinical Trial in Memphis, TN

About This Pediatric Osteosarcoma Study in Memphis

The purpose of this study is to assess the safety, feasibility, and effectiveness of a consolidative B7-H3 CAR T cell therapy in patients with newly diagnosed high-risk osteosarcoma who have undergone upfront standard chemotherapy. Primary Objectives: \- To evaluate 1-year RFS from the time of SJCARB7H3\_41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy. Secondary Objectives: * To evaluate the OS from time of SJCARB7H3\_41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy. * To evaluate the feasibility of delivering SJCARB7H3\_41BBL at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma. * To describe the safety of autologous SJCARB7H3\_41BBL therapy when delivered at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma.

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

Participant and/or legally authorized representative has signed the Informed Consent Form for this study

Prior cancer therapy:

Regimen A only: Completed all planned cycles of consolidation therapy between 14-28 days prior.

Regimen B only: has completed all planned cycles of consolidation chemotherapy at least 14 days prior and if clinically indicated, participant has undergone pulmonary metastasectomy. They must have recovered from any surgical complications with no ongoing sequelae of category 2 or higher by the Clavien-Dindo classification system and less than 6 weeks must have passed from time of pulmonary metastasectomy.

No evidence of progressive disease since enrolled on study

Lansky performance status score of ≥ 50 for participants \<16 years of age or Karnofsky score ≥ 50 for participants ≥ 16 years. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status

Adequate organ function as indicated by:

Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) based on enrollment eligibility table.

Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg/dL AND ALT (SGPT) ≤ 5 times ULN

Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram

Respiratory: Oxygen saturation ≥ 90% on room air without supplemental oxygen or mechanical ventilation

Laboratory values meet the following criteria:

Absolute Neutrophil Count (ANC) ≥ 750 cells/uL

Platelet Count of ≥ 75,000 (can be transfused)

Hemoglobin ≥ 7 g/dL (can be transfused)

Participant is ≥ 7 days from receiving supra-physiologic dosing of systemic (IV or PO) corticosteroids. Glucocorticosteroid physiologic replacement therapy for management of adrenal insufficiency is allowed.

Participant and/or legally authorized representative has signed the Informed Consent Form for the treatment phase of this study.

Exclusion Criteria

Major surgical adverse event related to the primary tumor local control defined as Clavien-Dindo category 3 requiring ongoing wound care.

Evidence of clinically significant encephalopathy/new focal neurologic deficits.

Presence of active severe infection, defined as:

positive blood culture within 48 hours of enrollment, OR

fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment

Participant has received prior disease-directed therapy other than 1st line therapy with methotrexate, an anthracycline, and a platinum and local control surgery • Regimen B only - okay to have undergone initial pulmonary metastasectomy

Pregnant or breastfeeding

Presence of any condition that, in the opinion of the investigator, would prohibit the participant from undergoing treatment under this protocol

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Memphis?

Yes, this clinical trial (NCT07428993) has an active research site in Memphis, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pediatric Osteosarcoma Treatment Options in Memphis, TN

If you're searching for pediatric osteosarcoma treatment options in Memphis, TN, this clinical trial (NCT07428993) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Memphis research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced pediatric osteosarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pediatric osteosarcoma clinical trials near you to find additional studies recruiting in your area.

Pediatric Osteosarcoma Clinical Trial in Memphis, TN

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