Overview

Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma

Status:
Not yet recruiting
Trial end date:
2026-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Hu5F9-G4
Immunoglobulins
Magrolimab
Pembrolizumab
Criteria
Inclusion Criteria:

- Age ≥ 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

- Biopsy proven relapsed or refractory cHL

- Prior treatment with at least two systemic therapies

- Metabolically active measurable disease by PET imaging per the 2014 Lugano criteria

- Hemoglobin ≥ 9.0 g/dL

- Absolute neutrophil count ≥ 1,000 cells/μL

- Platelet count ≥ 75,000 cells/μL

- Creatinine clearance > 40 mL/min per the Cockroft-Gault formula

- Total bilirubin < 1.5 x upper limit of normal (ULN) (or < 3.0 x ULN and primarily
unconjugated in subjects with a history of Gilbert's syndrome)

- Negative urine or serum pregnancy test within 30 days of enrollment and within 72
hours before the first administration of magrolimab for women of childbearing
potential

- Women of childbearing potential must be willing to use at least 1 highly effective
method of contraception during the study and continue for 4 months after the last dose
of magrolimab

- Male subjects who are sexually active with a woman of childbearing potential and who
have not had vasectomies must be willing to use a barrier method of contraception
during the study and for 4 months after the last dose of magrolimab

- Ability to understand and the willingness to sign the written IRB approved informed
consent document

- Must be willing and able to comply with the clinic visits and procedures outlined in
the study protocol

Exclusion Criteria:

- Prior treatment with antibodies targeting PD 1, PD L1, CD47, or Signal regulatory
protein α (SIRPα)

- Prior allogeneic hematopoietic cell transplantation

- Systemic autoimmune disorder on chronic immunosuppression (defined as ≥ 10 mg of
prednisone daily)

- History of hemolytic anemia, autoimmune thrombocytopenia, or Evan's syndrome within
the last 3 months

- Second malignancy not in complete remission for at least 1 year, excluding fully
resected non melanoma skin cancer or localized prostate cancer

- Pregnant or breast feeding

- HIV or hepatitis B or C infection with active viral replication by PCR

- Second malignancy not in complete remission for at least 1 year, excluding fully
resected non-melanoma skin cancer or localized prostate cancer

- Active cardiac disease including unstable angina, decompensated congestive heart
failure, or severe uncontrolled conduction abnormalities

- Significant medical conditions, as assessed by the investigators and IND holder, that
would substantially increase the risk benefit ratio of participating in the study

- History of psychiatric illness or substance abuse likely to interfere with ability to
comply with protocol requirements