Trial Outcomes & Findings for Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma (NCT NCT04788043)
NCT ID: NCT04788043
Last Updated: 2026-06-30
Results Overview
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").
TERMINATED
PHASE2
8 participants
Up to 2 years
2026-06-30
Participant Flow
Participant milestones
| Measure |
Magrolimab (Hu5F9 G4) and Pembrolizumab
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).
Magrolimab: 45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Pembrolizumab: 200 mg IV infusion
PET/CT: Scan
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Magrolimab (Hu5F9 G4) and Pembrolizumab
n=8 Participants
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).
Magrolimab: 45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Pembrolizumab: 200 mg IV infusion
PET/CT: Scan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: The study was terminated early due to discontinuation of magrolimab development. As a result, not all participants were followed for the full 2-year timeframe, and results are based on available data.
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").
Outcome measures
| Measure |
Magrolimab (Hu5F9 G4) and Pembrolizumab
n=8 Participants
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).
Magrolimab: 45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Pembrolizumab: 200 mg IV infusion
PET/CT: Scan
|
|---|---|
|
Complete Response (CR)
4 months
|
3 Participants
|
|
Complete Response (CR)
8 months
|
3 Participants
|
|
Complete Response (CR)
Overall (within 2 years)
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 4 monthsMagrolimab 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.
Outcome measures
| Measure |
Magrolimab (Hu5F9 G4) and Pembrolizumab
n=8 Participants
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).
Magrolimab: 45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Pembrolizumab: 200 mg IV infusion
PET/CT: Scan
|
|---|---|
|
Magrolimab Related Adverse Events
Grade 1 (Mild)
|
70 events
|
|
Magrolimab Related Adverse Events
Grade 2 (Moderate)
|
20 events
|
|
Magrolimab Related Adverse Events
Grade 3 (Severe)
|
6 events
|
|
Magrolimab Related Adverse Events
Grade 4 (Life-threatening)
|
0 events
|
|
Magrolimab Related Adverse Events
Grade 5 (Fatal)
|
0 events
|
SECONDARY outcome
Timeframe: up to 8 monthsPopulation: Eight participants were evaluable at the 4-month assessment. At the 8-month assessment, five participants were evaluable. Three participants were not evaluable at 8 months due to early study discontinuation (two due to adverse events and one due to study halt). One participant evaluated at 8 months had disease progression.
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).
Outcome measures
| Measure |
Magrolimab (Hu5F9 G4) and Pembrolizumab
n=8 Participants
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).
Magrolimab: 45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Pembrolizumab: 200 mg IV infusion
PET/CT: Scan
|
|---|---|
|
Overall Response (OR)
4 months
|
6 Participants
|
|
Overall Response (OR)
8 months
|
4 Participants
|
Adverse Events
Magrolimab (Hu5F9 G4) and Pembrolizumab
Serious adverse events
| Measure |
Magrolimab (Hu5F9 G4) and Pembrolizumab
n=8 participants at risk
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).
Magrolimab: 45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Pembrolizumab: 200 mg IV infusion
PET/CT: Scan
|
|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
Other adverse events
| Measure |
Magrolimab (Hu5F9 G4) and Pembrolizumab
n=8 participants at risk
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).
Magrolimab: 45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion
Pembrolizumab: 200 mg IV infusion
PET/CT: Scan
|
|---|---|
|
Investigations
Platelet count decreased
|
50.0%
4/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Renal and urinary disorders
Urine discoloration
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
White blood cell decreased
|
62.5%
5/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
50.0%
4/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
Lymphocyte count decreased
|
87.5%
7/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
Alanine Aminotransferase Increased
|
75.0%
6/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
Alkaline phosphatase increased
|
87.5%
7/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
6/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
Aspartate aminotransferase Increased
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
Blood bicarbonate decreased
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Investigations
Blood bilirubin increased
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Vascular disorders
Flushing
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
General disorders
Fatigue
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
General disorders
Fever
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Eye disorders
Floaters
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Nervous system disorders
Headache
|
50.0%
4/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
87.5%
7/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.5%
3/8 • From first dose until 30 days after the last dose of the study treatment, up to a maximum of 19 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place