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

Trial ID or NCT#

NCT04788043

Status

recruiting iconRECRUITING

Purpose

The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma.

Official Title

A Phase 2 Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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 ≥ 9.5 g/dL - Absolute neutrophil count ≥ 1,000 cells/μL without G-CSF support within 3 weeks prior to enrollment - 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:
  1. - Prior treatment with a PD-1 inhibitor within 3 months prior to enrollment - Prior treatment with antibodies targeting CD47 or SIRPα2 - Prior allogeneic hematopoietic cell transplantation - Systemic autoimmune disorder on chronic immunosuppression (defined as ≥ 10 mg of prednisone daily) - RBC transfusion dependence, defined as requiring more than 2 units of RBCs during the 4-week period prior to screening - 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 - Women who are 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 - History of non-infectious pneumonitis requiring corticosteroids or current pneumonitis - 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 - Received a live or live attenuated vaccine within 30 days before the first dose of study intervention - Received any anti-cancer therapy within 2 weeks prior to the first dose of study intervention
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Investigator(s)

Ranjana Advani
Ranjana Advani
Lymphoma specialist, Hematologist-Oncologist
Saul A. Rosenberg, MD, Professor of Lymphoma

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Contact

Austin Yeung
650-736-1908

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View on ClinicalTrials.gov