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Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02953509
Enrollment
178
Registered
2016-11-02
Start date
2016-11-21
Completion date
2024-03-25
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Hodgkin Lymphoma

Brief summary

The primary objectives of this study are: * To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx). * To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant (ASCT) ineligible DLBCL participants.

Interventions

DRUGMagrolimab

Administered intravenously

DRUGRituximab

Administered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13

DRUGGemcitabine

Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4

DRUGOxaliplatin

Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4

DRUGAllopurinol

Administered orally during Cycle 1

Sponsors

The Leukemia and Lymphoma Society
CollaboratorOTHER
Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key Inclusion Criteria: * Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies * DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL) expressing cluster of differentiation (CD) 20, relapsed or refractory to at least 2 prior lines treatment containing anti-CD20 therapy * Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies * DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment * Adequate performance status and hematological, liver and kidney functions * Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy Key

Exclusion criteria

* Active brain metastases * Prior allogeneic hematopoietic cell transplantation * Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents * Second malignancy within the last 3 years * Known active or chronic hepatitis B or C infection or HIV * Pregnancy or active breastfeeding * Prior chimeric antigen receptor (CAR-T) therapy Note: Other protocol defined Inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment CombinationUp to 28 daysDLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment CombinationUp to 28 daysDLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. DLT was defined as any Grade 3 or greater AE including Grade 4 hematologic toxicity that does not resolve to Grade 2 and delays initiation of cycle 2 by more than 14 days, Grade 4 febrile neutropenia or associated infections, Grade 4 non-hematologic toxicity that does not resolve or decrease to Grade 2 within 1 week, Grade 4 infusion-related reaction (IRR), and recurrent Grade 3 or greater IRR despite optimal pretreatment regimen that was assessed as related to either magrolimab, rituximab, gemcitabine, or oxaliplatin and occurred during the 4-week DLT observation period. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)Up to 7.2 yearsTEAE's were defined as any AEs with an onset date on or after the study drug start date, no later than 30 days after last dose of any study drug or day before initiation of subsequent line of anti-cancer therapy, whichever is earlier, or the AEs leading to the discontinuation of the study drug. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution.
Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for LymphomasUp to 7.3 yearsORR:CR(complete metabolic response(CMR);complete radiological response(CRR)) or PR(partial metabolic response(PMR);partial radiologic response(PRR)).CMR:PET 5 point-scale(5PS) with 1(no uptake above background,2(uptake≤mediastinum),3(uptake\>mediastinum but≤liver)with/without residual mass;no new lesions;no fluorodeoxyglucose (FDG)-avid disease in bone marrow(BM).CRR:target nodes/nodal masses regressed ≤1.5cm in longest transverse diameter of lesion(LDi);no extra lymphatic disease sites;absent non-measured lesions(NMLs);organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with reduced uptake from baseline & residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed \>50% length beyond normal; no new sites.

Secondary

MeasureTime frameDescription
Duration of Response (DOR)Up to 7.3 yearsDOR is measured from when first OR is met(CR or PR)until the first date of documented progressive disease\[progressive metabolic disease(PMD);progressive radiologic disease(PRD)\]while on study prior to start of next line anti-cancer therapy.Participants with no progressive disease were censored at last response assessment date.Response assessment post start of anti-cancer therapy was excluded from derivation.OR defined in outcome measure 4.PMD:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with increased uptake from baseline;new FDG-avid foci consistent with lymphoma rather than another etiology;new or recurrent FDG-avid foci in BM.PRD:LDi \>1.5 cm;≥ 50% increase from cross product of LDi & perpendicular diameter(PPD);increase in LDi or shortest axis perpendicular to LDi(SDi) of 0.5 cm for lesions ≤ 2 & 1 cm for lesions \>2 cm;spleen increased by \>50% in length beyond normal;new or recurrent splenomegaly,BM involved;new lesions;progression of pre-existing lesions.
Progression Free Survival (PFS)Up to 7.3 yearsPFS is measured from dose initiation until the first date of objectively documented disease progression (PMD; PRD) or death while on study prior to start of the subsequent line of anti-cancer therapy. Participants who do not have progressive disease & not died were censored at last response assessment date.Response assessments after initiation of the subsequent line of anti-cancer therapy will be excluded from derivation. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake from baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in BM. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi & PPD; increase in LDi or SDi of 0.5 cm for lesions ≤ 2 & 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, BM involvement; new lesions; progression of pre-existing lesions. KM estimates of median was reported.
PK Parameter of Magrolimab: AUClastPhase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)AUClast is defined as the concentration of drug from time zero to the last observable concentration. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Time to Progression (TTP)Up to 7.3 yearsTTP is measured from dose initiation until the first date of objectively documented progressive disease criteria while on study prior to start of next line anti-cancer therapy. Participants with no progressive disease were censored at last response assessment date. Response assessment post start of anti-cancer therapy was excluded from derivation. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; = 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions =1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-meier (KM) estimates of median was reported.
ORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for LymphomasUp to 7.3 yearsObjective response is defined as complete response or partial response determined by LYRIC criteria. ORR:CR\[CMR;CRR\] or PR\[PMR;PRR\].CMR:PET 5 PS with 1(no uptake above background,2(uptake≤mediastinum),3(uptake\>mediastinum but≤liver)with/without residual mass;no new lesions;no FDG-avid disease in BM.CRR:target nodes/nodal masses regressed to ≤1.5cm in LDi;no extralymphatic disease sites;absent NMLs;organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with reduced uptake from baseline and residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR: ≥50% decrease in sum of product of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed \>50% in length beyond normal;no new sites.
Overall Survival (OS)Up to 7.3 yearsOS is measured from dose initiation until death.
PK Parameter of Magrolimab: AUCtauPhase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
PK Parameter of Magrolimab: CmaxPhase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)Cmax is defined as the maximum observed concentration of drug. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Percentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)Up to 4 years

Countries

Australia, United Kingdom, United States

Participant flow

Recruitment details

Participants were enrolled at study sites in Australia, the United Kingdom, and the United States.

Pre-assignment details

209 participants were screened.

Participants by arm

ArmCount
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days. The maximum duration of treatment was up to approximately 86.6 months.
3
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days. The maximum duration of treatment was up to approximately 83.3 months.
6
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days. The maximum duration of treatment was up to approximately 67.9 months.
13
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days. The maximum duration of treatment was up to approximately 29.2 months.
7
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only. The maximum duration of treatment was up to approximately 23.2 months.
26
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only. The maximum duration of treatment was up to approximately 10.8 months.
7
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days. The maximum duration of treatment was up to approximately 59.9 months.
43
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days. The maximum duration of treatment was up to approximately 15.7 months.
14
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days. The maximum duration of treatment was up to approximately 57.4 months.
31
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days. The maximum duration of treatment was up to approximately 35.3 months.
28
Total~(N=178)178
Total356

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009
Overall StudyConsent Withdrawn1121304114
Overall StudyDeath133412325102120
Overall StudyLost to Follow-up0000001111
Overall StudyReason Not Specified028211412272
Overall StudyStudy terminated by sponsor1000001011

Baseline characteristics

CharacteristicPhase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPhase 1b Cohort 3: Magrolimab 30 mg/kg + RituximabPhase 1b Cohort 4: Magrolimab 45 mg/kg + RituximabPhase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + OxaliplatinPhase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + OxaliplatinPhase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPhase 2 Cohort 1: Magrolimab 30 mg/kg + RituximabPhase 2 Cohort 2: Magrolimab 30 mg/kg + RituximabPhase 2 Cohort 3: Magrolimab 45 mg/kg + RituximabPhase 2 Cohort 4: Magrolimab 30 mg/kg + RituximabTotal~(N=178)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants5 Participants3 Participants17 Participants4 Participants1 Participants22 Participants12 Participants23 Participants20 Participants108 Participants
Age, Categorical
Between 18 and 65 years
5 Participants8 Participants4 Participants9 Participants3 Participants2 Participants21 Participants2 Participants8 Participants8 Participants70 Participants
Age, Continuous60 years
STANDARD_DEVIATION 11.3
61 years
STANDARD_DEVIATION 11.4
63 years
STANDARD_DEVIATION 15.2
65 years
STANDARD_DEVIATION 14.4
70 years
STANDARD_DEVIATION 9.5
58 years
STANDARD_DEVIATION 12.8
62 years
STANDARD_DEVIATION 13.2
71 years
STANDARD_DEVIATION 6.7
70 years
STANDARD_DEVIATION 11.5
70 years
STANDARD_DEVIATION 12.4
66 years
STANDARD_DEVIATION 12.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants1 Participants1 Participants0 Participants2 Participants0 Participants3 Participants2 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants12 Participants7 Participants24 Participants4 Participants3 Participants41 Participants14 Participants28 Participants24 Participants162 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants1 Participants2 Participants0 Participants0 Participants0 Participants0 Participants2 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants5 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants0 Participants2 Participants0 Participants0 Participants2 Participants0 Participants1 Participants1 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants3 Participants2 Participants0 Participants1 Participants0 Participants1 Participants3 Participants11 Participants
Race (NIH/OMB)
White
4 Participants10 Participants7 Participants20 Participants5 Participants3 Participants39 Participants14 Participants28 Participants24 Participants154 Participants
Region of Enrollment
Australia
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants4 Participants4 Participants
Region of Enrollment
United Kingdom
0 Participants0 Participants0 Participants2 Participants0 Participants0 Participants4 Participants1 Participants3 Participants2 Participants12 Participants
Region of Enrollment
United States
6 Participants13 Participants7 Participants24 Participants7 Participants3 Participants39 Participants13 Participants28 Participants22 Participants162 Participants
Sex: Female, Male
Female
3 Participants5 Participants1 Participants10 Participants2 Participants2 Participants16 Participants4 Participants15 Participants9 Participants67 Participants
Sex: Female, Male
Male
3 Participants8 Participants6 Participants16 Participants5 Participants1 Participants27 Participants10 Participants16 Participants19 Participants111 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
deaths
Total, all-cause mortality
1 / 34 / 65 / 134 / 712 / 263 / 726 / 4310 / 1422 / 3121 / 28
other
Total, other adverse events
3 / 36 / 613 / 137 / 725 / 267 / 742 / 4314 / 1431 / 3127 / 28
serious
Total, serious adverse events
2 / 32 / 66 / 131 / 721 / 265 / 719 / 439 / 1421 / 3111 / 28

Outcome results

Primary

Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas

ORR:CR(complete metabolic response(CMR);complete radiological response(CRR)) or PR(partial metabolic response(PMR);partial radiologic response(PRR)).CMR:PET 5 point-scale(5PS) with 1(no uptake above background,2(uptake≤mediastinum),3(uptake\>mediastinum but≤liver)with/without residual mass;no new lesions;no fluorodeoxyglucose (FDG)-avid disease in bone marrow(BM).CRR:target nodes/nodal masses regressed ≤1.5cm in longest transverse diameter of lesion(LDi);no extra lymphatic disease sites;absent non-measured lesions(NMLs);organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with reduced uptake from baseline & residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed \>50% length beyond normal; no new sites.

Time frame: Up to 7.3 years

Population: The Efficacy Analysis Set included all enrolled participants who received at least 1 dose of magrolimab. As prespecified in the statistical analysis plan (SAP), the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).

ArmMeasureValue (NUMBER)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas0 percentage of participants
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas0 percentage of participants
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas50.0 percentage of participants
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas20.6 percentage of participants
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas60.0 percentage of participants
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas26.1 percentage of participants
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas33.3 percentage of participants
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas46.2 percentage of participants
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabObjective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas71.4 percentage of participants
Primary

Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

TEAE's were defined as any AEs with an onset date on or after the study drug start date, no later than 30 days after last dose of any study drug or day before initiation of subsequent line of anti-cancer therapy, whichever is earlier, or the AEs leading to the discontinuation of the study drug. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution.

Time frame: Up to 7.2 years

Population: The Safety Analysis Set included all participants who received at least 1 dose of any study treatment.

ArmMeasureValue (NUMBER)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)96.2 percentage of participants
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)97.7 percentage of participants
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPercentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)100.0 percentage of participants
Primary

Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination

DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.

Time frame: Up to 28 days

Population: The DLT Analysis Set 1 (Antibody Combination) included all enrolled Phase 1b participants in the magrolimab + rituximab cohort who met either of the following criteria:~* The participant experienced a DLT~* The participants completed at least 3 infusions of magrolimab and 2 infusions of rituximab.

ArmMeasureValue (NUMBER)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPhase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination0 percentage of participants
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPhase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination16.7 percentage of participants
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPhase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination15.4 percentage of participants
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPhase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination16.7 percentage of participants
Primary

Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination

DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b. DLT was defined as any Grade 3 or greater AE including Grade 4 hematologic toxicity that does not resolve to Grade 2 and delays initiation of cycle 2 by more than 14 days, Grade 4 febrile neutropenia or associated infections, Grade 4 non-hematologic toxicity that does not resolve or decrease to Grade 2 within 1 week, Grade 4 infusion-related reaction (IRR), and recurrent Grade 3 or greater IRR despite optimal pretreatment regimen that was assessed as related to either magrolimab, rituximab, gemcitabine, or oxaliplatin and occurred during the 4-week DLT observation period. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.

Time frame: Up to 28 days

Population: The DLT Analysis Set 2 (Chemotherapy Combination)included all enrolled Phase 1b participants in the magrolimab + rituximab, gemcitabine,and oxaliplatin (R-GemOx) cohort who met either of the following criteria in DLT assessment period:~* Participants had DLT at any time after initiation of first infusion of magrolimab, rituximab, and gemcitabine or oxaliplatin~* Participants completed at least 3 infusions of magrolimab, 2 infusions of rituximab, and 1 infusion of gemcitabine and oxaliplatin

ArmMeasureValue (NUMBER)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPhase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination0 percentage of participants
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPhase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination16.7 percentage of participants
Secondary

Duration of Response (DOR)

DOR is measured from when first OR is met(CR or PR)until the first date of documented progressive disease\[progressive metabolic disease(PMD);progressive radiologic disease(PRD)\]while on study prior to start of next line anti-cancer therapy.Participants with no progressive disease were censored at last response assessment date.Response assessment post start of anti-cancer therapy was excluded from derivation.OR defined in outcome measure 4.PMD:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with increased uptake from baseline;new FDG-avid foci consistent with lymphoma rather than another etiology;new or recurrent FDG-avid foci in BM.PRD:LDi \>1.5 cm;≥ 50% increase from cross product of LDi & perpendicular diameter(PPD);increase in LDi or shortest axis perpendicular to LDi(SDi) of 0.5 cm for lesions ≤ 2 & 1 cm for lesions \>2 cm;spleen increased by \>50% in length beyond normal;new or recurrent splenomegaly,BM involved;new lesions;progression of pre-existing lesions.

Time frame: Up to 7.3 years

Population: Participants in the Efficacy Analysis Set with an objective response (CR + PR) and those who had objective response without a subsequent event of disease progression/death were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).

ArmMeasureValue (MEDIAN)
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabDuration of Response (DOR)NA months
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabDuration of Response (DOR)NA months
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinDuration of Response (DOR)5.5 months
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinDuration of Response (DOR)15.9 months
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabDuration of Response (DOR)21.2 months
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabDuration of Response (DOR)11.3 months
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabDuration of Response (DOR)NA months
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabDuration of Response (DOR)18.0 months
Secondary

ORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas

Objective response is defined as complete response or partial response determined by LYRIC criteria. ORR:CR\[CMR;CRR\] or PR\[PMR;PRR\].CMR:PET 5 PS with 1(no uptake above background,2(uptake≤mediastinum),3(uptake\>mediastinum but≤liver)with/without residual mass;no new lesions;no FDG-avid disease in BM.CRR:target nodes/nodal masses regressed to ≤1.5cm in LDi;no extralymphatic disease sites;absent NMLs;organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with reduced uptake from baseline and residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR: ≥50% decrease in sum of product of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed \>50% in length beyond normal;no new sites.

Time frame: Up to 7.3 years

Population: Participants in the Efficacy Analysis Set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).

ArmMeasureValue (NUMBER)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas0 percentage of participants
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas0 percentage of participants
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas50.0 percentage of participants
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas22.1 percentage of participants
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas60.0 percentage of participants
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas26.1 percentage of participants
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas33.3 percentage of participants
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas46.2 percentage of participants
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas71.4 percentage of participants
Secondary

Overall Survival (OS)

OS is measured from dose initiation until death.

Time frame: Up to 7.3 years

Population: Participants in the Efficacy Analysis Set with available were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).

ArmMeasureValue (MEDIAN)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabOverall Survival (OS)13.9 months
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabOverall Survival (OS)NA months
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabOverall Survival (OS)32.2 months
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinOverall Survival (OS)8.5 months
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinOverall Survival (OS)NA months
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabOverall Survival (OS)14.0 months
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabOverall Survival (OS)23.7 months
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabOverall Survival (OS)41.4 months
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabOverall Survival (OS)NA months
Secondary

Percentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)

Time frame: Up to 4 years

Population: The ADA analysis set included participants with at least one reported ADA result where participants evaluable for ADA incidence were defined as participants with non-missing baseline sample and at least one sample taken after drug administration during the treatment or follow-up observation period that are appropriate for ADA testing (with reportable result). As prespecified in SAP,ADA results were to be reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.

ArmMeasureValue (NUMBER)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)6.7 percentage of participants
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)7.7 percentage of participants
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPercentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)0 percentage of participants
Secondary

PK Parameter of Magrolimab: AUClast

AUClast is defined as the concentration of drug from time zero to the last observable concentration. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.

Time frame: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)

Population: The Pharmacokinetics (PK) Analysis Set included all participants who received at least 1 dose of study drug and had measurable concentrations of magrolimab from PK blood samples. Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.

ArmMeasureGroupValue (MEAN)Dispersion
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)770 day*micrograms(μg)/milliliters(mL)Standard Deviation 346
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)1470 day*micrograms(μg)/milliliters(mL)Standard Deviation 431
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)4260 day*micrograms(μg)/milliliters(mL)Standard Deviation 1050
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)1810 day*micrograms(μg)/milliliters(mL)Standard Deviation 426
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)2300 day*micrograms(μg)/milliliters(mL)Standard Deviation 280
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)2220 day*micrograms(μg)/milliliters(mL)Standard Deviation 877
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 8 (Cycle 1, Day 8)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 1 (Cycle 1, Day 1)NA day*micrograms(μg)/milliliters(mL)
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUClastDay 29 (Cycle 2, Day 1)NA day*micrograms(μg)/milliliters(mL)
Secondary

PK Parameter of Magrolimab: AUCtau

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.

Time frame: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)

Population: Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.

ArmMeasureGroupValue (MEAN)Dispersion
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)671 day*μg/mL
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)1220 day*μg/mLStandard Deviation 97
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)4260 day*μg/mLStandard Deviation 1050
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)1810 day*μg/mLStandard Deviation 426
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)2300 day*μg/mLStandard Deviation 280
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)2080 day*μg/mLStandard Deviation 658
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 8 (Cycle 1, Day 8)NA day*μg/mL
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 1 (Cycle 1, Day 1)NA day*μg/mL
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: AUCtauDay 29 (Cycle 2, Day 1)NA day*μg/mL
Secondary

PK Parameter of Magrolimab: Cmax

Cmax is defined as the maximum observed concentration of drug. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.

Time frame: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)

Population: Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.

ArmMeasureGroupValue (MEAN)Dispersion
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)212 μg/mLStandard Deviation 54.6
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)0.619 μg/mL
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)330 μg/mLStandard Deviation 123
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)903 μg/mLStandard Deviation 186
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)1.32 μg/mLStandard Deviation 1.31
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)485 μg/mLStandard Deviation 114
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)NA μg/mL
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)NA μg/mL
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)924 μg/mLStandard Deviation 170
Phase 1b Cohort 4: Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)1862 μg/mLStandard Deviation 411
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)NA μg/mL
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)NA μg/mL
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)2096 μg/mLStandard Deviation 449
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)906 μg/mLStandard Deviation 160
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)0.477 μg/mLStandard Deviation 0.178
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)567 μg/mLStandard Deviation 75.7
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)542 μg/mLStandard Deviation 188
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)0.496 μg/mLStandard Deviation 0.353
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)NA μg/mL
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)NA μg/mL
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)NA μg/mL
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)NA μg/mL
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)918 μg/mLStandard Deviation 251
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)1858 μg/mLStandard Deviation 321
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)904 μg/mLStandard Deviation 414
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)2186 μg/mLStandard Deviation 615
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)NA μg/mL
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)NA μg/mL
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 8 (Cycle 1, Day 8)NA μg/mL
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 1 (Cycle 1, Day 1)NA μg/mL
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + RituximabPK Parameter of Magrolimab: CmaxDay 29 (Cycle 2, Day 1)NA μg/mL
Secondary

Progression Free Survival (PFS)

PFS is measured from dose initiation until the first date of objectively documented disease progression (PMD; PRD) or death while on study prior to start of the subsequent line of anti-cancer therapy. Participants who do not have progressive disease & not died were censored at last response assessment date.Response assessments after initiation of the subsequent line of anti-cancer therapy will be excluded from derivation. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake from baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in BM. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi & PPD; increase in LDi or SDi of 0.5 cm for lesions ≤ 2 & 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, BM involvement; new lesions; progression of pre-existing lesions. KM estimates of median was reported.

Time frame: Up to 7.3 years

Population: Participants in the efficacy analysis set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).

ArmMeasureValue (MEDIAN)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabProgression Free Survival (PFS)1.6 months
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabProgression Free Survival (PFS)NA months
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabProgression Free Survival (PFS)5.6 months
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinProgression Free Survival (PFS)1.8 months
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinProgression Free Survival (PFS)7.5 months
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabProgression Free Survival (PFS)2.1 months
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabProgression Free Survival (PFS)5.5 months
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabProgression Free Survival (PFS)3.9 months
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabProgression Free Survival (PFS)20.3 months
Secondary

Time to Progression (TTP)

TTP is measured from dose initiation until the first date of objectively documented progressive disease criteria while on study prior to start of next line anti-cancer therapy. Participants with no progressive disease were censored at last response assessment date. Response assessment post start of anti-cancer therapy was excluded from derivation. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; = 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions =1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-meier (KM) estimates of median was reported.

Time frame: Up to 7.3 years

Population: Participants in the Efficacy Analysis Set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).

ArmMeasureValue (MEDIAN)
Phase 1b Cohort 1: Magrolimab 10 mg/kg + RituximabTime to Progression (TTP)1.6 months
Phase 1b Cohort 2: Magrolimab 20 mg/kg + RituximabTime to Progression (TTP)NA months
Phase 1b Cohort 3: Magrolimab 30 mg/kg (Loading Dose) + RituximabTime to Progression (TTP)5.6 months
Phase 1b Cohort 5: Magrolimab 30 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinTime to Progression (TTP)1.8 months
Phase 1b Cohort 6: Magrolimab 45 mg/kg (Loading Dose) + Rituximab + Gemcitabine + OxaliplatinTime to Progression (TTP)7.9 months
Phase 2 Cohort 1 (DLBCL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabTime to Progression (TTP)2.0 months
Phase 2 Cohort 1 (iNHL): Magrolimab 30 mg/kg (No Loading Dose) + RituximabTime to Progression (TTP)5.6 months
Phase 2 Cohort 2 (DLBCL): Magrolimab 30 mg/ kg (Loading Dose) + RituximabTime to Progression (TTP)3.9 months
Phase 2 Cohort 2 (iNHL): Magrolimab 30 mg/kg (Loading Dose) + RituximabTime to Progression (TTP)20.3 months

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026