CAR T Cells for Embryonal Cancer
(SABRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment for certain childhood cancers that have returned or are not responding to standard treatments. The treatment uses special immune cells (T cells) modified to attack cancer cells. Specifically, it involves Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells. The trial seeks participants with specific cancers, such as rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor, who have not had success with other treatments. Participants should have a measurable tumor and not have used steroids recently. 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 be stopped before participation. For example, you must wait at least 3 weeks after myelosuppressive chemotherapy and monoclonal antibodies, and at least 7 days after hematopoietic growth factors. It's best to discuss your specific medications with the trial team to understand any necessary changes.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that B7-H3 CAR T cells might not harm normal tissues that also express B7-H3. This finding is significant because it suggests the treatment might not attack healthy cells. Additionally, these cells have demonstrated good growth and memory cell formation, indicating potential long-term effectiveness.
However, as this is a phase I study, researchers are primarily focused on understanding safety and determining the appropriate dose. In phase I trials, the treatment is tested in humans for the first time, so information about its side effects is limited. This phase aims to ensure the treatment's safety and establish the correct dose.
Overall, while lab studies provide some encouraging data, safety in humans is still being established at this early stage. Participants will be closely monitored for any side effects, particularly during the first 28 days after treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment for embryonal cancer because it combines selective antigen-specific dTβRII-expressing T cells with B7-H3 CAR T cells, offering a novel approach to attacking cancer cells. Unlike traditional treatments such as surgery, radiation, or chemotherapy, which can affect healthy tissues, this treatment focuses on harnessing the body's immune system to target cancer cells more precisely. The unique combination of these T cells aims to improve the precision and effectiveness of the immune response, potentially reducing damage to healthy cells and enhancing overall outcomes for patients.
What evidence suggests that this treatment might be an effective treatment for embryonal cancer?
Research has shown that a new treatment using CAR T cells, which target a protein called B7-H3 found in many cancers, shows promise in early tests for treating children's solid tumors, including brain tumors. These CAR T cells are designed to find and attack cancer cells by recognizing specific proteins on them. Early results suggest this method could help treat cancers such as rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, and Wilms tumor. In this trial, participants will receive a combination of B7-H3 CAR T cells with another type of T cell targeting a different cancer protein. This combined approach might enhance effectiveness, potentially leading to improved outcomes for patients. Although detailed results in humans remain limited, early lab studies are encouraging.12456
Who Is on the Research Team?
Amy Hont, MD
Principal Investigator
Children's National Research Institute
Holly Meany, MD
Principal Investigator
Children's National Research Institute
Are You a Good Fit for This Trial?
This trial is for individuals with relapsed/refractory embryonal tumors like rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, and Wilms tumor. Participants must have tried previous treatments without success. Specific inclusion and exclusion criteria are not provided but typically involve health status and prior therapies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procurement
Participants undergo a non-mobilized apheresis for collection of mononuclear cells for CAR-TA T cell product manufacturing
Treatment
Participants receive lymphodepleting chemotherapy followed by CAR-TA T cell infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells
Trial Overview
The study tests a combination of two types of T cells: Selective Antigen Specific dTβRII-expressing T cells and B7-H3 CAR T cells after chemotherapy to see if they're safe and work against certain pediatric cancers. It's in the early phase where researchers find the best dose.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Lymphodepleting chemotherapy regimen with cyclophosphamide and fludarabine will be administered prior to CAR-TA T cell product infusion. The DNR-TA T cells and B7-H3 CAR T cells will be generated and combined into a final product comprised of the two T cell components combined at a 1:1 ratio.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
The Mark Foundation for Cancer Research
Collaborator
Cancer Research UK
Collaborator
Citations
NCT07172958 | Selective Antigen Specific T Cells and ...
This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME ...
2.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07172958?term=%22circular+RNA%22+OR+circRNA+OR+oncology&aggFilters=status%3Arec+not+enr%2CstudyType%3AintNCT07172958 | Selective Antigen Specific T Cells and CAR ...
This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME ...
CAR T Cells for Embryonal Cancer · Info for Participants
... Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells will have tolerable side effects & efficacy for patients with Ewing ...
Selective Antigen Specific T Cells and CAR T ...
This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME ...
CAR T Cells Targeting B7-H3, a Pan-Cancer Antigen ...
CAR T cells targeting B7-H3, a pan-cancer antigen, demonstrate potent preclinical activity against pediatric solid tumors and brain tumors.
B7-H3 CAR-T(National Cancer Institute)
B7-H3.CAR-T effectively and promoted proliferation and differentiation into memory cells. MRS.B7-H3.CAR-T was not cytotoxic in normal tissues expressing B7-H3 ...
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