Overview

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
All
Summary
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. rHSC-DIPGVax is an off-the-shelf neo-antigen heat shock protein containing 16 peptides reflecting neo-epitopes found in the majority of DIPG and DMG tumors. Newly diagnosed patients with DIPG and DMG who have completed radiation six to ten weeks prior to enrollment are eligible.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators:
Children's Hospital of Orange County
Dana-Farber Cancer Institute
Treatments:
Iodine
Vaccines
Criteria
Inclusion Criteria:

- Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are
eligible for study enrollment. Biopsy is not required for subjects with
radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's
and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology
report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and
diffuse involvement of more than 2/3 of the pons.

= Subjects ages > or = to 12 months and < or = 18 years ("Lead In", Part A, and Part B
require first three patients be > or = to 12 years of age)

- BSA > or = 0.35m2 at the time of study enrollment

- Performance score: Karnofsky >50% of subjects >16 years of age and Lansky > or = 50
for subjects < or = 16 years of age. Subjects who are unable to walk because of
paralysis but are up in a wheelchair will be considered ambulatory for the purpose of
assessing the performance score.

- Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must
be within 42 days to 70 days post radiation (6-10 weeks)

- Corticosteroids should be weaned as tolerated after radiation therapy with the goal of
< or = 0.5mg/kg/day for a minimum of 7 days prior to enrollment.

- Subjects must have measurable disease

Exclusion Criteria:

- Disseminated disease

- Subjects who have received any cancer therapy except for radiation

- Autoimmune or immune disorders

- Active respiratory disorder or infection

- Active viral infection