41 Participants NeededMy employer runs this trial

B7-H3 CAR T Cell Therapy for Bone Cancer

Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with high-risk bone cancer, specifically osteosarcoma. It aims to determine if a special therapy using B7-H3 CAR T cells (engineered immune cells) can safely and effectively assist those who have already undergone standard chemotherapy. The trial will assess whether this therapy can prevent cancer recurrence and improve survival rates. Potential participants should have completed chemotherapy for newly diagnosed metastatic osteosarcoma and show no signs of tumor progression. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 7 days from receiving high doses of corticosteroids (a type of steroid medication).

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that B7-H3 CAR T cell therapy is safe and well-tolerated. For example, one study found that this treatment did not cause serious side effects in patients with recurrent glioblastoma, a type of brain cancer. Patients experienced no dose-limiting toxicities, indicating they could handle the treatment even at higher doses.

Other research has demonstrated that B7-H3 CAR T cells effectively target and kill cancer cells while maintaining a good safety profile. In studies involving different cancers, such as osteosarcoma, the treatment was well-tolerated. This suggests that the therapy could be safe for patients with high-risk bone cancer, like osteosarcoma.

Overall, evidence suggests that B7-H3 CAR T cells could be a promising and safe option for treating certain cancers. However, like any treatment, side effects can occur, so discussing trial participation with healthcare providers is important.12345

Why do researchers think this study treatment might be promising for bone cancer?

Researchers are excited about the B7-H3 CAR T Cell Therapy for bone cancer because it offers a novel approach to treatment by genetically modifying a patient's own immune cells to specifically target and destroy cancer cells. Unlike traditional treatments like chemotherapy and radiation, which can affect both healthy and cancerous cells, CAR T cell therapy is designed to hone in on the cancer cells, potentially reducing side effects and improving efficacy. This therapy uses a unique mechanism by incorporating a protein called B7-H3, which is often overexpressed in cancer cells, allowing the modified T cells to better recognize and attack the tumor. This innovative approach represents a promising advance in the fight against bone cancer, particularly for patients who may not respond well to standard therapies.

What evidence suggests that B7-H3 CAR T cell therapy could be an effective treatment for bone cancer?

Research has shown that B7-H3 CAR T cell therapy, which participants in this trial may receive, could be a promising treatment for osteosarcoma, a type of bone cancer. Studies have found that these CAR T cells can successfully destroy osteosarcoma cells with the B7-H3 marker. Specifically, targeting B7-H3 with CAR T cells led to significantly smaller tumors in early animal tests. Initial results suggest that this therapy might be safe and effective for aggressive osteosarcoma cases that are difficult to treat. While early data appears promising, further research is needed to confirm these benefits in humans.23567

Who Is on the Research Team?

JP

Julie Park, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for people with newly diagnosed high-risk osteosarcoma (a type of bone cancer) who have finished standard chemotherapy and meet certain health requirements, like good heart, liver, kidney, and lung function. Participants must be able to care for themselves or move around in a wheelchair.

Inclusion Criteria

My liver tests are within the allowed range for this study.
* Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram
* Absolute Neutrophil Count (ANC) ≥ 750 cells/uL
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Chemotherapy

Participants receive standard chemotherapy including methotrexate, anthracycline, and platinum

Approximately 31 weeks

Apheresis and CAR T Cell Manufacture

Participants undergo apheresis for SJCARB7H3_41BBL manufacture prior to local control surgery

Approximately 12 weeks after diagnosis

Lymphodepletion and CAR T Cell Infusion

Participants receive lymphodepletion chemotherapy followed by SJCARB7H3_41BBL infusion

14-28 days after completion of standard chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after CAR T cell infusion

24 months post-infusion

What Are the Treatments Tested in This Trial?

Interventions

  • SJCARB7H3_41BBL

Trial Overview

The study is testing B7-H3 CAR T cell therapy (SJCARB7H3_41BBL infusion) given after standard chemotherapy to see if it helps prevent the cancer from coming back. All participants receive this new treatment after their usual chemo.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: 3CAR4OS TreatmentExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

Citations

B7-H3 targeted CAR-T cells show highly efficient anti-tumor ...

The results showed that the B7-H3 CAR-T cells had an excellent killing effect on the four target-positive osteosarcoma cells, while the control group had no ...

3CAR: B7-H3-specific CAR T-cell Therapy for Children and ...

This study looks at a new treatment for children and young adults with solid tumors that have been difficult to treat (refractory) or have come back after ...

NCT07428993 | Evaluating Efficacy of B7-H3-CAR T Cells ...

This is a phase 2 study of SJCARB7H3_41BBL for participants with newly diagnosed high-risk metastatic osteosarcoma who received standard chemotherapy. All ...

B7-H3 CAR T Cell Therapy for Bone Cancer

The purpose of this study is to assess the safety, feasibility, and effectiveness of a consolidative B7-H3 CAR T cell therapy in patients ...

Redirecting B7-H3.CAR T Cells to Chemokines Expressed in ...

Cell therapy with chimeric antigen receptor (CAR) T cells has been successful for B-cell malignancies leading to their FDA approval (6–8).

Targeting osteosarcoma with canine B7-H3 CAR T cells and ...

The goal of the present study was to generate canine CAR T cells targeting the B7-H3 (CD276) co-stimulatory molecule overexpressed by several solid cancers.

Abstract 3291: Development of anti-B7H3 CAR T cells for ...

We hypothesize that anti-B7H3 CAR T cells will be able to successfully lyse osteosarcoma in a canine model. We have verified that B7H3 is ...