A Phase 2 interventional study of Magrolimab and Pembrolizumab in Hodgkin Lymphoma, Classic Hodgkin Lymphoma and Relapsed Classical Hodgkin Lymphoma, sponsored by Ranjana Advani. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Ranjana Advani · Phase 2, Interventional, and Treatment
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:
885 studies on the registry are indexed under Hodgkin Disease; 132 are open to participants now.
This study's enrollment of 8 is below the median of 44 across 726 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →Ranjana Advani is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: Magrolimab · Drug: Pembrolizumab · Procedure: PET/CT
45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Also known as: Hu5F9-G4, ONO-7913, anti-CD47 monoclonal antibody Hu5F9-G4
200 mg IV infusion
Also known as: Keytruda, MK-3475, SCH 900475, anti-PD-1 monoclonal antibody MK-3475
Scan
Also known as: Positron Emission Tomography - Computed Tomography (PET/CT)
Complete Response (CR)
Each participant's response to treatment will be assessed per the Lugano criteria. The criteria are: * Complete Response (CR): Complete disappearance of all lesions, evidence, and effects of disease * Partial Response (PR): ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease * Stable disease (SD): less than PR. * Progressive disease (PD): sum of the product of dimensions (SPD) of lesions increased ≥50% from smallest value The outcome will be reported as the number of participants with a CR after 4 and 8 cycles of treatment (4 and 8 months), and if CR is achieved anytime within 2 years ("overall").
Time frame: Up to 2 years
Magrolimab Related Adverse Events
Magrolimab safety and tolerability will be assessed on the basis of magrolimab related adverse events occurring within 4 cycles of treatment (4 months). The outcome will be reported as the number of magrolimab related adverse events judged mild (Grade 1), moderate (Grade 2), severe (Grade 3), life threatening (Grade 4), or fatal (Grade 5), numbers without dispersion.
Time frame: up to 4 months
Overall Response (OR)
Overall response (OR) is defined as the sum of participants who achieve a complete response (CR) plus the number of participants who achieve a partial response (PR). Treatment response will be assessed per the Lugano criteria (aka the Cheson criteria). The criteria are: * CR: Complete disappearance of all lesions, evidence, and effects of disease * PR: ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease * Stable disease (SD): less than PR. * Progressive disease (PD): sum of the product of dimensions (SPD) of lesions increased ≥50% from smallest value The outcome will be reported as the number of participants with either a CR or a PR after 4 and 8 cycles of treatment (4 and 8 months). For participants who undergo a subsequent stem cell transplant, the value will be recorded as the time to transplant (censored).
Time frame: up to 8 months
| Milestone | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| Started | 8 |
| Completed | 3 |
| Not completed | 5 |
Each participant's response to treatment will be assessed per the Lugano criteria. The criteria are: * Complete Response (CR): Complete disappearance of all lesions, evidence, and effects of disease * Partial Response (PR): ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease * Stable disease (SD): less than PR. * Progressive disease (PD): sum of the product of dimensions (SPD) of lesions increased ≥50% from smallest value The outcome will be reported as the number of participants with a CR after 4 and 8 cycles of treatment (4 and 8 months), and if CR is achieved anytime within 2 years ("overall").
| Participants | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| 4 months | 3 |
| 8 months | 3 |
| Overall (within 2 years) | 3 |
Magrolimab safety and tolerability will be assessed on the basis of magrolimab related adverse events occurring within 4 cycles of treatment (4 months). The outcome will be reported as the number of magrolimab related adverse events judged mild (Grade 1), moderate (Grade 2), severe (Grade 3), life threatening (Grade 4), or fatal (Grade 5), numbers without dispersion.
| events | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| Grade 1 (Mild) | 70 |
| Grade 2 (Moderate) | 20 |
| Grade 3 (Severe) | 6 |
| Grade 4 (Life-threatening) | 0 |
| Grade 5 (Fatal) | 0 |
Overall response (OR) is defined as the sum of participants who achieve a complete response (CR) plus the number of participants who achieve a partial response (PR). Treatment response will be assessed per the Lugano criteria (aka the Cheson criteria). The criteria are: * CR: Complete disappearance of all lesions, evidence, and effects of disease * PR: ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease * Stable disease (SD): less than PR. * Progressive disease (PD): sum of the product of dimensions (SPD) of lesions increased ≥50% from smallest value The outcome will be reported as the number of participants with either a CR or a PR after 4 and 8 cycles of treatment (4 and 8 months). For participants who undergo a subsequent stem cell transplant, the value will be recorded as the time to transplant (censored).
| Participants | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| 4 months | 6 |
| 8 months | 4 |
Collected over From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Magrolimab (Hu5F9 G4) and Pembrolizumab | 1/8 (12.5%) | 2/8 (25%) | 8/8 (100%) |
| Event | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| Infusion related reactionInjury, poisoning and procedural complications | 1/8 |
| Mucositis oralGastrointestinal disorders | 1/8 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/8 |
| Event | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| Alkaline phosphatase increasedInvestigations | 7/8 |
| HyperglycemiaMetabolism and nutrition disorders | 7/8 |
| Lymphocyte count decreasedInvestigations | 7/8 |
| Alanine Aminotransferase IncreasedInvestigations | 6/8 |
| AnemiaBlood and lymphatic system disorders | 6/8 |
| White blood cell decreasedInvestigations | 5/8 |
| DiarrheaGastrointestinal disorders | 4/8 |
| HeadacheNervous system disorders | 4/8 |
| Infusion-related reactionInjury, poisoning and procedural complications | 4/8 |
| NauseaGastrointestinal disorders | 4/8 |
| Age, Categorical(Participants) | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| Female | 4 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Magrolimab (Hu5F9 G4) and Pembrolizumab |
|---|---|
| United States | 8 |
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Ranjana Advani