- Attending Physician, Hematology, Oncology, Neuro-Oncology and Stem Cell Transplantation, Ann & Robert H. Lurie Children’s Hospital of Chicago
- A.M. Khokhar Research Scholar, Ann & Robert H. Lurie Children’s Hospital of Chicago
- Associate Professor of Pediatrics (Hematology, Oncology, and Stem Cell Transplantation), Northwestern University Feinberg School of Medicine
Ashley Plant-Fox, MD, specializes in pediatric neuro-oncology and is recognized for her expertise in immunotherapy and the treatment of diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and other high grade gliomas. Dr. Plant-Fox is currently the lead Principal Investigator of an investigator-initiated, early phase clinical trial for rHSC-DIPGVax, a neoantigen specific heat shock protein vaccine, for the treatment of DIPG/DMG. In addition to Ann & Robert H. Lurie Children’s Hospital of Chicago, three other sites are currently enrolling patients on this study: Dana Farber Cancer Institute, Children’s Hospital Orange County, and Alberta Children’s. Dr. Plant-Fox is currently the Lurie Children’s site Principal Investigator for multiple pediatric clinical trial consortiums including PNOC and CONNECT. She also sits on the NCCN pediatric neuro-oncology subcommittee which contributes to national standard practice guidelines for the treatment of high grade glioma. Dr. Plant-Fox dreams of finding a way to use the body’s own immune system to cure aggressive high grade gliomas in children and reduce or eliminate long term effects of current treatments. Dr. Plant-Fox is also passionate about health disparities and working towards the more equitable treatment of patients with pediatric brain tumors.
Education and Background
- Fellowship in Pediatric Hematology Oncology, Boston Children’s Hospital 2013–2016
- Residency in Pediatrics, University of Los Angeles California Medical Center 2010–2013
- MD, Stanford University School of Medicine 2010
A PHASE I CLINICAL TRIAL PLUS EXPANSION ARM OF RHSC-DIPGVAX PLUS CHECKPOINT BLOCKADE FOR THE TREATMENT OF NEWLY DIAGNOSED DIPG AND DMG
This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB using a 3+3 design for subjects with newly diagnosed DIPG or DMG following completion of radiation therapy. Given this is a first in-human study of rHSC-DIPGVax, an initial study “Lead In” will assess the tolerability of vaccine monotherapy first in older children (12 to 18 years of age) followed by younger children (12 months to 18 years of age).
Sequential Parts A and B of this study will also first enroll patients 12 to 18 years of age before enrolling younger children. The rationale for the combination of vaccine and anti-PD1 therapy includes evidence of a more profound intra-tumoral response with addition of inhibition of negative co-regulatory pathways, such as, PD1/PDL1 and the need to overcome potentially immunosuppressive or immune “cold” microenvironment of gliomas. Anti-CLTA4 therapy will also be combined with rHSC-DIPGVax in the dose escalation portion of this study because of the ability of anti-CTLA4 therapy to induce T cell priming to promote T memory formation. Given the lack of standard treatment options for DIPG and DMG patients, this clinical trial will use combinatorial immunotherapy in upfront treatment of these patients in hopes of maximizing potential efficacy in this at-risk population while still assessing safety throughout.
Part A will evaluate rHSC-DIPGVax plus BALSTILIMAB. Pharmacokinetics (PK) of BALSTILIMAB will also be evaluated to assess exposure. If the rHSC-DIPGVax plus BALSTILIMAB is well tolerated in Part A for 28-days, this study will then move to enrolling Part B to evaluate the safety and tolerability of rHSC-DIPGVax and BALSTILIMAB in combination with ZALIFRELIMAB at two dose levels for a total therapy duration of one year or 27 cycles, whichever occurs first.
Advancement from Part A to Part B and dose escalation in Part B will follow a conservative 3+3 design. The dose limiting toxicity (DLT) monitoring period will last 28 days (2 cycles) for Part A subjects and 42 days (1 cycle) for Part B. Subjects will be allowed to continue in Part A for twenty-seven 14-day cycles or nine 42-day cycles in Part B or 1 year of total therapy, whichever comes first.
After the RP2D of ZALIFRELIMAB is determined, Part C, the expansion arm, will enroll further subjects at this dose level to assess futility versus efficacy. All subjects in trial Part C will be monitored for dose limiting toxicities for the duration of their participation in the study to monitor for excess toxicity.
A.M. Khokhar Research Scholar
Team Jack Foundation Grant
PCRF–Will Irwin Family Foundation Research Scholar