EWSR1 Immunotherapy in Ewing Sarcoma and DSRCT

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Rabi Hanna
Study ID
NCT07695311
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Desmoplastic Small Round Cell Tumor
  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EWSR1 immunotherapy — DRUG
    Participants will receive EWSR1 immunotherapy at 50 micrograms (mcg) (or 25 mcg for children 12 years and younger) through an intramuscular injection on Weeks 0, 4, 12 and 24.
  • Botensilimab — DRUG
    Participants will receive Botensilimab (anti-CTLA-4) at 1 milligram per kilogram (mg/kg) intravenously (through an IV) on Weeks 0, 4, 12, and 24.
  • Balstilimab — DRUG
    Participants will receive Balstilimab (anti-PD1) at 3 milligram per kilogram (mg/kg) intravenously (through an IV) on Week 0 and then every 2 weeks for 6 months.

Study Details

This study is for people who have high-risk Ewing sarcoma (ES), or a related Ewing's family tumor, desmoplastic small round cell tumor (DSRCT). The purpose of this study is to see if a new EWSR1 immunotherapy (a lipid nanoparticle coated with EWSR1 mRNA) which is given as a shot is safe and whether it can help the body's immune system better recognize and fight cancer. This EWSR1 immunotherapy is designed to target a specific genetic change (EWSR1 fusion gene) that is found in cancer cells but not in normal, healthy cells. Because the EWSR1 gene is broken in cancer cells and the small protein it makes are only in the ES or DSRCT cancer cells, the goal of EWSR1 immunotherapy is to help the immune system identify and attack the cancer without harming normal cells. It is not yet approved by the Food and Drug Administration (FDA). EWSR1 immunotherapy will be given as a shot into the muscle of the arm, leg, or buttock. If participants also receive botensilimab (4 doses after each EWSR1 immunotherapy shot) and balstilimab (an infusion every 2 weeks), these are given intravenously (IV) by a needle in the arm over 30 minutes. Participants in this study will receive treatment for about 6 months or until their cancer gets worse. Participants will remain in the study for follow-up for an additional year, for a total time of about 1.5 years in the study.

Key Dates

First listed
Jul 10, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy cohort
    First, a safety cohort of participants will be enrolled in the study. Participants will receive EWSR1 immunotherapy on Weeks 0, 4, 12 and 24.
  • Experimental: Combination cohort
    After safety is established through the monotherapy cohort, participants will be enrolled in the combination cohort. Participants will receive EWSR1 immunotherapy on Weeks 0, 4, 12 and 24. Participants will also receive Botensilimab (anti-CTLA-4) at on Weeks 0, 4, 12, and 24. Participants will also receive Balstilimab (anti-PD1) on Week 0 and then every 2 weeks for 6 months.

Primary Outcome Measure

Safety of EWSR1 immunotherapy, measured by number of participants with grade 4 immunotherapy-related adverse events [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteClevelandOhio44195
Rabi Hanna, MD
[email protected]
216-407-8655
Rabi Hanna, MD (PRINCIPAL_INVESTIGATOR)
Peter M Anderson, MD, PhD (SUB_INVESTIGATOR)
Matteo Trucco, MD (SUB_INVESTIGATOR)
Timothy A Chan, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute· Cleveland, OH

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