study of magrolimab and pembrolizumab in relapsed or refractory classic hodgkin lymphoma

Conditions: Hodgkin Lymphoma; Classic Hodgkin Lymphoma; Relapsed Classical Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma

Summary: the purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with hodgkin lymphoma.

primary objectives: - to assess the complete remission (cr) rate of magrolimab in combination with pembrolizumab in adult subjects with relapsed or refractory chl secondary objectives: * to assess the safety and tolerability of magrolimab in combination with pembrolizumab in adult subjects with relapsed or refractory chl * to assess the overall response rate (orr)

Eligibility 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 ≥ 9.5 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: * 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