Hodgkin LymphomaPhase 2NCT04788043
Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
A Phase 2 study testing Magrolimab, Pembrolizumab and PET/CT in people with Hodgkin Lymphoma and Classic Hodgkin Lymphoma, run by Ranjana Advani at 2 sites in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Relapsed Classical Hodgkin Lymphoma
- What is being tested?
- Magrolimab, Pembrolizumab and PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2022to 29 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Stanford University
Stanford, California, 94304
About this study
Official title: A Phase 2 Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma.
Read the detailed description
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)
- Conditions
- Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Relapsed Classical Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
- Being tested
- Magrolimab, Pembrolizumab, PET/CT
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagrolimabDrug
Also called Hu5F9-G4, ONO-7913, anti-CD47 monoclonal antibody Hu5F9-G4
45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
PembrolizumabDrug
Also called Keytruda, MK-3475, SCH 900475, anti-PD-1 monoclonal antibody MK-3475
200 mg IV infusion
PET/CTProcedure or surgery
Also called Positron Emission Tomography - Computed Tomography (PET/CT)
Scan
| Study group | Role | What they receive |
|---|---|---|
| Magrolimab (Hu5F9 G4) and pembrolizumab | Experimental | 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). Receives: Drug: Magrolimab; Drug: Pembrolizumab; Procedure: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Up to 2 years
Secondary outcomes (2)
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.
Measured: 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).
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start21 Jun 2022
- Primary completion11 Oct 2024
- Study completion29 Aug 2025
Why it stopped: Discontinuation of magrolimab development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranjana Advani
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Ranjana Advani, Stanford University
- Investigators
- Ranjana H Advani, MD, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788043
- Sponsor's protocol ID
- IRB-56995
- Other IDs
- LYMHD0019, NCI-2022-05298
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2021
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04788043
- Acronym / sponsor ID
- IRB-56995
- Conditions
- Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Relapsed Classical Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of magrolimab development
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ranjana AdvaniUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magrolimab (Hu5F9 G4) and pembrolizumab | Experimental | Drug: Magrolimab, Drug: Pembrolizumab, Procedure: PET/CTAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagrolimabAlso: Hu5F9-G4, ONO-7913, anti-CD47 monoclonal antibody Hu5F9-G445 mg/kg with dose escalation starting at 1 mg/kg IV Infusion | Drug | Magrolimab (Hu5F9 G4) and pembrolizumab |
| PembrolizumabAlso: Keytruda, MK-3475, SCH 900475, anti-PD-1 monoclonal antibody MK-3475200 mg IV infusion | Drug | Magrolimab (Hu5F9 G4) and pembrolizumab |
| PET/CTAlso: Positron Emission Tomography - Computed Tomography (PET/CT)Scan | Procedure or surgery | Magrolimab (Hu5F9 G4) and pembrolizumab |
Primary outcome
Complete Response (CR)
Time frame: Up to 2 years
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").
2 secondary outcomes
Magrolimab Related Adverse Events
Time frame: up to 4 months
Overall Response (OR)
Time frame: up to 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjana H Advani, MD principal investigator
Stanford Universiy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magrolimab, Pembrolizumab and PET/CT in people with Hodgkin Lymphoma and Classic Hodgkin Lymphoma, run by Ranjana Advani at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.