B7-H3 CAR T Cells for Solid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cell therapy called B7-H3 CAR T cells to determine its safety and effectiveness in treating solid cancers in children and young adults. It specifically targets cancers that have returned or are unresponsive to standard treatments and display a B7-H3 marker. Participants will receive two chemotherapy drugs, Fludarabine and Cyclophosphamide, before the cell therapy. Suitable candidates for this trial have a solid tumor that has recurred or is unresponsive to treatment and has a B7-H3 marker. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, there are specific time requirements for stopping certain treatments before joining the trial, such as waiting periods after chemotherapy or radiation therapy. It's best to discuss your current medications with the trial team to understand how they might affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that B7-H3 CAR T cells have been tested for safety in treating solid tumors in children and young adults. These studies indicate that patients can safely receive the treatment. Some reports mention that the therapy is generally well-tolerated, with patients showing signs that the treatment reaches the tumor and has anti-tumor effects.
It is important to note that this treatment remains in the early stages of testing. While some safety information is available, more research is needed to fully understand any possible risks or side effects. As the trial is in an early phase, the treatment's safety continues to be assessed, but initial results are promising regarding its tolerability.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for solid cancers, which often involve chemotherapy, surgery, or radiation, B7-H3.CD28Z.CART therapy is a type of CAR T-cell therapy that specifically targets the B7-H3 protein on cancer cells. This targeted approach means that the therapy can directly attack cancer cells with potentially fewer side effects on healthy cells. Researchers are excited because this innovative therapy harnesses the patient's own immune system to fight cancer, offering a more personalized and potentially more effective treatment option for those with difficult-to-treat solid tumors.
What evidence suggests that B7-H3 CAR T cells might be an effective treatment for solid cancer?
Research has shown that B7-H3 CAR T cells, which participants in this trial may receive, could be a promising treatment for solid tumors in children and young adults. These specially designed cells can locate and attack cancer cells with the B7-H3 marker. In lab tests, B7-H3 CAR T cells successfully shrank tumors. Early trials suggested these cells can safely reach and combat tumors. Although this treatment remains in the early stages, the initial results offer hope for those whose tumors haven't responded to other treatments.12567
Who Is on the Research Team?
Natalie Collins, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for children and young adults with solid tumors, including neuroblastoma, that have relapsed or are refractory. Participants must have tumors marked by B7-H3 to be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis
Autologous T-cell collection for CAR T manufacturing prior to lymphodepletion
Lymphodepleting Chemotherapy
Fludarabine and cyclophosphamide administered intravenously to prepare for CAR T-cell infusion
Treatment
Single IV B7-H3.CD28Z.CART infusion with post-infusion monitoring
Follow-up
Safety and disease assessments through 24 months, then annual long-term gene-therapy follow-up to 15 years
Optional Second Infusion
Allowed ≥60 days and ≤2 years after first, with repeat lymphodepletion and same follow-up
What Are the Treatments Tested in This Trial?
Interventions
- B7-H3.CD28Z.CART
- Cyclophosphamide
- Fludarabine
Trial Overview
The study tests the safety and effectiveness of a new cell therapy called B7-H3.CD28Z.CART in treating solid cancers. It's given alongside two chemotherapy drugs: Fludarabine and Cyclophosphamide.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
3+3 dose-escalation to define maximum tolerated dose (MTD) and Phase 2 Recommended Dose (RP2D) of autologous B7-H3.CD28Z.CART cells, followed by 2 expansion cohorts (neuroblastoma; other B7-H3-positive solid tumors) at RP2D. * Screening/Baseline: Consent, eligibility, history, exam, performance status, labs (incl. HIV, hepatitis, pregnancy), ECG, echocardiogram (as indicated), imaging and/or bone marrow, neurologic exam. * Leukapheresis: Autologous T-cell collection for CAR T manufacturing prior to lymphodepletion. * Lymphodepleting chemotherapy (Days -4 to -2): Fludarabine + cyclophosphamide IV. * Day 0: Single IV B7-H3.CD28Z.CART infusion (inpatient), with ≥7 days post-infusion monitoring. * Follow-up: Safety and disease assessments through 24 months, then annual long-term gene-therapy follow-up to 15 years. * Optional second infusion: Allowed ≥60 days and ≤2 years after first, with repeat lymphodepletion and same follow-up.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Robbie Majzner
Lead Sponsor
Band of Parents
Collaborator
Citations
NCT07358260 | B7-H3.CD28Z.CART in Solid Tumors
The goal of this research study is to test if a new cell therapy (B7-H3.CD28Z.CART / B7-H3 CAR T cells) is safe and effective in treating ...
CAR T cells redirected to B7-H3 for pediatric solid tumors - PMC
In this article we review B7-H3-targeted chimeric antigen receptor (B7-H3-CAR) T cell therapies for pediatric solid tumors, reporting preclinical development ...
3.
aacrjournals.org
aacrjournals.org/cancerres/article/85/18_Supplement_2/A018-PR014/765586/Abstract-A018-PR014-B7-H3-CAR-T-cells-expressingB7-H3-CAR T cells expressing 41BB ligand for pediatric solid ...
B7-H3-CAR T cells can be safely infused in pediatric patients with r/r solid tumors with evidence of homing to tumor sites and antitumor ...
315 Improving pediatric neuroblastoma ...
Conclusions These preliminary results suggest there may be a benefit of delivering low-dose tumor-directed EBRT in mice receiving B7-H3 CAR-T ...
Development and evaluation of novel CAR-T Cell therapy
The B7-H3-CAR-T cells effectively lysed these tumor cells, as evidenced by a significant decrease in the normalized cell index over time compared to NC-T cells ...
Safety and efficacy of B7-H3 targeting CAR-T cell therapy ...
In this trial, treating rGBM with TX103 is deemed safe and tolerated. These interim results support further study using TX103 to enhance the survival outcomes.
Stanford CAR-T solid tumor study enrolls first pediatric patient
This study's CAR-T cells target the B7-H3 antigen on cancer cells. B7H3 is expressed in many solid tumors and some brain tumors in both children ...
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