Magrolimab + Pembrolizumab for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByRanjana H Advani, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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

Eligibility Criteria

Adults over 18 with relapsed or refractory classic Hodgkin Lymphoma (cHL) who've had at least two prior treatments can join. They must have a certain level of blood cells, organ function, and no recent severe illnesses or second cancers. Participants need to use effective birth control and not be pregnant.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I have undergone at least two different treatments for my condition.

My white blood cell count is healthy without needing medication.

I have taken a pregnancy test recently and it was negative.

I am a man who can father a child and will use contraception during and 4 months after the study.

My Hodgkin lymphoma has returned or is not responding to treatment.

I am 18 years old or older.

My PET scan shows active cancer.

Exclusion Criteria

I have had a stem cell transplant from a donor.

I have not taken PD-1 inhibitors in the last 6 months.

I have previously been treated with drugs targeting CD47 or SIRPα2.

I have a serious heart condition that is not under control.

I have had lung inflammation treated with steroids or have it now.

I am on long-term immunosuppression for an autoimmune disorder.

I have HIV or hepatitis B/C with active virus replication.

I am not pregnant or breastfeeding.

I needed more than 2 blood transfusions in the last month.

Participant Groups

The trial is testing the combination of Magrolimab and Pembrolizumab for safety and effectiveness in treating cHL. Patients will undergo PET/CT imaging to measure disease activity before and during treatment.

1Treatment groups

Experimental Treatment

Group I: Magrolimab (Hu5F9 G4) and pembrolizumabExperimental Treatment3 Interventions

All subjects will have a baseline PET CT and excisional or core needle biopsy within 1 month of study enrollment and baseline electrocardiogram and laboratory studies within 1 week of study enrollment. All subjects will receive treatment with magrolimab and pembrolizumab according to the dosing schedule. Magrolimab IV given on cycle 1, 2 and 3. Pembrolizumab 200 mg IV given on Cycle 1, 2 and 3. Patients may continue to receive treatment on the study for a maximum of 24 months or until progression of disease, unacceptable toxicity, or bridge to stem cell transplantation (SCT).