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