B7-H3-CAR T Cells + Radiation for Childhood Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for children and young adults under 21 with certain cancers that have returned or resisted standard treatment. It combines a special cell therapy called B7-H3-CAR T cells with radiation and chemotherapy to assess safety and effectiveness. The trial seeks participants with specific types of sarcomas, such as osteosarcoma or Ewing sarcoma, that have relapsed or are treatment-resistant. As a Phase 1 trial, this research aims to understand 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 you stop taking systemic steroid therapy exceeding a certain dose 7 days before the CAR T cell infusion and any systemic therapy 14 days before starting the trial treatment. If you're on these medications, you may need to stop or adjust them.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that B7-H3-CAR T cells, a type of cell therapy for cancer, have been tested in early studies and appear well-tolerated. One study found that using these cells in children and young adults was manageable, with patients not experiencing severe side effects. Another study discovered that these CAR T cells did not mistakenly attack healthy cells.
These findings suggest the treatment is relatively safe, but it's important to remember that this trial is in its first phase. This phase focuses on assessing safety, so while results are promising, the full safety picture is still emerging. Participants in this trial will contribute to gathering more information about the treatment's safety and effectiveness.12345Why are researchers excited about this trial's treatments?
Researchers are excited about B7-H3-CAR T Cells because they offer a novel approach to treating childhood cancer by targeting the B7-H3 protein, which is often present on cancer cells but not on most normal cells. Unlike traditional chemotherapy, which can affect both cancerous and healthy cells, CAR T Cells are engineered to specifically seek out and destroy cancer cells, potentially leading to fewer side effects. Additionally, combining this targeted therapy with radiation and lymphodepleting chemotherapy could enhance its effectiveness, offering a new hope for better outcomes in young patients battling cancer.
What evidence suggests that B7-H3-CAR T cells combined with radiation might be an effective treatment for childhood cancer?
Research has shown that B7-H3-CAR T cells, which participants in this trial will receive, are highly active against solid tumors in children. These cells target a protein called B7-H3, found in many cancers, and have proven effective in early lab studies. Animal tests have demonstrated promising results for difficult childhood cancers, such as osteosarcoma. Another study supported their potential for various childhood cancers, indicating they can effectively attack cancer cells. Early human trials suggested that these treatments can be administered safely, even in challenging cases like brain tumors.26789
Who Is on the Research Team?
Rebecca Epperly, MD
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for pediatric patients aged 21 or younger with relapsed/refractory sarcomas that express B7-H3. Participants must have tried standard treatments without success and be able to handle the side effects of chemotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and Manufacturing
Peripheral blood mononuclear cells (PBMC) are collected by autologous apheresis for CAR T cell manufacturing
Treatment
Participants receive hypofractionated radiation therapy (HFRT) and lymphodepleting chemotherapy followed by B7-H3-CAR T cell infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and dose limiting toxicities
Optional Additional Treatment
Participants who meet specified criteria may be eligible for optional additional treatment courses
What Are the Treatments Tested in This Trial?
Interventions
- B7-H3-CAR T Cells
- Cyclophosphamide
- Fludarabine
- Hypofractionated Radiation Therapy
Trial Overview
The RAD3CAR study tests the safety of a new therapy combining B7-H3-CAR T cells with hypofractionated radiation and lymphodepleting chemo (Fludarabine, Cyclophosphamide) in young patients with specific sarcomas.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Peripheral blood mononuclear cells (PBMC) will be collected by autologous apheresis. Treatment will include HFRT to at least one site of disease, administered in parallel with a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) and followed by CAR T cell infusion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
Citations
CAR T cells redirected to B7-H3 for pediatric solid tumors
CAR T cells targeting B7-H3, a pan-cancer antigen, demonstrate potent preclinical activity against pediatric solid tumors and brain tumors.
CAR T Cells Targeting B7-H3, a Pan-Cancer Antigen ...
B7-H3 CAR T cells show significant in vivo activity against a range of xenograft models of lethal childhood cancers, including orthotopic models of osteosarcoma ...
3.
scholarlyexchange.childrensmercy.org
scholarlyexchange.childrensmercy.org/researchdays/GME_Research_Days_2024/ResearchDay3/2/Therapeutic Efficacy of B7-H3 CAR T Cell Therapy In ...
This study aims to assess the potential of anti-B7-H3 CAR T cell therapy in treating the challenging pHGG tumors.
CAR T-Cell Study Suggests Promise for Childhood Cancers
A CAR T-cell therapy targeting the B7-H3 protein may have potential as a treatment for several childhood cancers, results from a study in ...
Intracerebroventricular B7-H3-targeting CAR T cells for ...
This completed first-in-human trial shows that repetitive ICV dosing of B7-H3 CAR T cells in pediatric and young adult patients with DIPG is tolerable.
CAR T cells redirected to B7-H3 for pediatric solid tumors
Based on the encouraging preclinical data and safety profile, B7-H3 CAR T cells are now being evaluated in early phase clinical studies. Table 1 outlines “ ...
CAR T-cell therapy landscape in pediatric, adolescent and ...
For instance, systemic administration of B7-H3 CAR-T cells has shown significant regression and eradication of osteosarcoma, Ewing sarcoma, and medulloblastoma ...
Safety and Efficacy of CMD03 CAR T Cell in Children With ...
A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after ...
STRIvE-02: A First-in-Human Phase I Study of Systemically ...
B7-H3 CAR T cells are tolerable and demonstrate limited antitumor activity without acute on-target, off-tumor toxicity. High levels of CAR T ...
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