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PNOC025: Magrolimab in Children and Adults with Recurrent or Progressive Malignant Brain Tumors

Summary

The goal of this study is to test the safety and efficacy of magrolimab in children and adults with recurrent or progressive malignant brain tumors. Magrolimab is a novel antibody anticancer therapeutic agent targeting a certain protein called CD47. Binding of magrolimab to CD47 on target malignant cells blocks the "don't eat me" signal by cancer cells and enhances tumor cell phagocytosis. Other early “pre-clinical” studies have shown that treatment with magrolimab leads to prolonged survival in models of Atypical Teratoid Rhabdoid Tumors (ATRT), diffuse intrinsic pontine glioma (DIPG), high-grade glioma (adult and pediatric), medulloblastoma, and embryonal tumors formerly called Primitive Neuro-Ectodermal Tumors (PNET). Safety studies in humans have proven that magrolimab has an excellent safety profile. Ongoing studies are currently testing magrolimab in adult myelodysplastic syndromes, acute myeloid leukemia, non-Hodgkin lymphoma, colorectal, ovarian, and bladder cancers.

Trial Information

What to expect:

  • Patients meeting inclusion criteria will receive intravenous (IV) infusions of magrolimab as part of their study participation for the treatment of their brain tumor.

  • Patients will be divided into two groups based on age, Stratum A: 3-17, Stratum B: ≥ 18 years of age

  • Participants may continue      to receive magrolimab for up to 12 months or longer from the time of study      entry, pending discussion with study chairs and study sponsor.

Approach

Treatment:

  • Each participant will receive magrolimab intravenously      (IV):

  • Cycle 0: Priming dose of 1 mg/kg during Cycle 0

  • Cycles 1 and 2: Either 30 mg/kg or 45mg mg/kg dose weekly for eight weeks

  • All additional cycles: Either 30 mg/kg or 45 mg/kg dose every two weeks for the remainder of the study.

  • Patients will be followed for adverse events related to      study agent for a minimum of 12 months.

  • Participants will be followed for clinical outcomes for      up to years after completion of Magrolimab treatment.

Additional Information

NCT05169944

Full Details on ClinicalTrials.Gov

This trial is available at University of California, San Francisco & University of Utah

Eligibility

Inclusion Criteria

  • Age 3 years and older

  • Diagnosis of recurrent or progressive malignant primary brain tumor

  • Histologic confirmation of malignancy at original diagnosis or relapse

  • Must have measurable disease

  • Life expectancy ≥8 weeks

  • Lansky or Karnofsky score ≥50

  • Patient must have failed at least one prior therapy with or without surgery

  • Last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study entry

  • Must have recovered from any acute toxicity and received their last dose of biologic agent ≥7  days prior to study entry

  • At least 28 days or 4 half-lives, whichever is shorter, since last monoclonal antibody treatment prior to study entry

  • Must be ≥3 months since autologous bone marrow/stem cell transplant prior to study entry

  • Last dose of radiotherapy ≥12 weeks prior to study entry (palliative radiation ≥14 days)

  • Patients on steroids must be on stable or decreasing dose for at least 7 days prior to study entry

  • Appropriate organ function

  • Appropriate laboratory values

  • Adequate neurologic function

  • Females and males of childbearing age must agree to use appropriate contraception

  • Willing to sign informed consent/assent


Exclusion Criteria

  • Receiving other investigational therapeutic agents

  • History of allergic reactions to drugs similar to magrolimab

  • Uncontrolled illness

  • Pregnant or breastfeeding

  • Prior positive HIV, Hepatitis B, or Hepatitis C test

  • Prior treatment with CD47 or SIRP targeting agents

  • Prior hemolytic anemia or Evans Syndrome in the past 3 months

  • Red blood cell transfusion dependent

  • Active autoimmune disease that has required treatment in the past two years

  • Participants with midline or primary spinal cord tumors

  • At risk for imminent herniation

  • Contraindication to MRI

  • Hemosiderosis/hemochromatosis or iron overload

  • Received a live vaccine within the last 30 days

Contact Information

Principal Investigator: Sabine Mueller, MD, PhD

View Investigator Page


Additional Contacts: Aubrie Drechsler

Email: PNOC025@ucsf.edu

Phone: (415) 502-1600

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