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

NCT02953509 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 5F90032016-003408-29
• Study Type: interventional
• Target: 178
• Locations: 3 countries
• Sites: 20

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.

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 28 days

• 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.

  Up to 28 days

• 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.

  Up to 7.2 years

• 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.

  Up to 7.3 years

Secondary Outcomes (9)

• PK Parameter of Magrolimab: AUClast

  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)

• PK Parameter of Magrolimab: AUCtau

  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)

• PK Parameter of Magrolimab: Cmax

  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)

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

  Up to 4 years

• Duration of Response (DOR)

  Up to 7.3 years

Study Arms (10)

Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab

EXPERIMENTAL

Participants with B-cell non-hodgkin's lymphoma (NHL) will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab

EXPERIMENTAL

Participants with B-cell NHL will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab

EXPERIMENTAL

Participants with B-cell NHL will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab

EXPERIMENTAL

Participants with B-cell NHL will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin

EXPERIMENTAL

Autologous stem cell transplant ineligible diffuse large B-cell lymphoma (DLBCL) participants will receive 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.Cycle length will be 28 days.Rituximab 375 mg/m\^2 IV infusion will be given 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 will be administered on Day 1 of every other cycle(on even cycles).Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion will be given as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4.Granulocyte colony stimulating factor (G-CSF) prophylaxis will be given with gemcitabine and oxaliplatin treatment(Cycles 1-4).Allopurinol 300 mg orally daily will be administered for the first cycle only.

Drug: Magrolimab; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Allopurinol

Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin

EXPERIMENTAL

Autologous stem cell transplant ineligible DLBCL participants will receive 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 of 28 days. Rituximab 375 mg/m\^2 IV infusion will be 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 will be administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion will be administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis will be administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily will be administered for the first cycle only.

Drug: Magrolimab; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Allopurinol

Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab

EXPERIMENTAL

Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab

EXPERIMENTAL

Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab

EXPERIMENTAL

Participants with B-cell iNHL (including FL and MZL) and DLBCL will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab

EXPERIMENTAL

Participants with DLBCL will receive 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 will be administered on Day 1 of every other cycle (on even cycles). Each Cycle length of 28 days.

Drug: Magrolimab; Drug: Rituximab

Interventions

Magrolimab DRUG

Administered intravenously

Also known as: Hu5F9-G4

Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab; Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab; Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab; Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab; Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin; Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin; Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab; Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab; Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab; Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab

Rituximab DRUG

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

Also known as: RITUXAN®, MabThera

Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab; Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab; Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab; Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab; Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin; Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin; Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab; Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab; Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab; Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab

Gemcitabine DRUG

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

Also known as: Gemzar®

Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin; Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin

Oxaliplatin DRUG

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

Also known as: Eloxatin®

Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin; Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin

Allopurinol DRUG

Administered orally during Cycle 1

Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin; Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (20)

University of Alabama At Birmingham (Uab)

Birmingham, Alabama, 35924, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

National Institutes of Health Clinical Center/ National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

St. Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

The Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (14)

• Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, Kline J, Roschewski M, LaCasce A, Collins GP, Tran T, Lynn J, Chen JY, Volkmer JP, Agoram B, Huang J, Majeti R, Weissman IL, Takimoto CH, Chao MP, Smith SM. CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2018 Nov 1;379(18):1711-1721. doi: 10.1056/NEJMoa1807315.

  PMID: 30380386 BACKGROUND

• Advani R, Volkmer JP, Chao MP. CD47 Blockade and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2019 Jan 31;380(5):497-498. doi: 10.1056/NEJMc1816156. No abstract available.

  PMID: 30699313 BACKGROUND

• Mehta A, Popplewell L, Collins GP, Smith S, Flinn I, Bartlett NL, et al. Magrolimab in Combination With Rituximab in Patients With Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: 3-Year Follow-up Results From a Phase 1/2 Trial. Am J Hematol 2022;97:S3-S40.

  BACKGROUND

• Maakaron J, Asch AS, Popplewell LL, Collins GP, Flinn IW, Ghosh N, et al. Magrolimab in Combination with Rituximab + Chemotherapy in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Blood 2022;140 (Supplement 1):3728-3730.

  BACKGROUND

• Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. Activity of thefirst-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.

  BACKGROUND

• Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 + rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 15th International Conference on Malignant Lymphoma (ICML); 2019 18-22 June; Lugano, Switzerland.

  BACKGROUND

• Roschewski M, Advani R, Bartlett NL, Smith SM, Popplewell L, Flinn I, et al. Activity of the first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab in relapsed/refractory Non-Hodgkin's lymphoma: interim Phase 1b/2 results [Presentation]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.

  BACKGROUND

• Advani R, Bartlett NL, Smith SM, Roschewski M, Popplewell L, Flinn I, et al. The first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab induces durable responses in relapsed/refractory DLBCL and indolent lymphoma: Interim Phase 1b/2 results [Abstract]. 24th Congress of the European Hematology Association (EHA); 2019 13-16 June; Amsterdam, Netherlands.

  BACKGROUND

• Wang B, Jin D, Cho MM, Takimoto C, Chao M, Agoram B. Magrolimab (Hu5F9-G4, 5F9) Treatment Does Not Alter Rituximab Pharmacokinetics in Patients With Non-Hodgkin's Lymphoma [Poster THU-008]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.

  BACKGROUND

• Wang B, Jin D, Takimoto C, Chao M, Agoram B. Magrolimab Treatment Does Not Alter Rituximab Pharmacokinetics in Patients with Non-Hodgkin's Lymphoma [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.

  BACKGROUND

• Jin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population-Pharmacokinetics of Magrolimab (Hu5F9-G4, 5F9) in Patients With Solid Tumors and Lymphomas [Poster TUE-020]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.

  BACKGROUND

• Jin DCY, Wang B, Sikic B, Advani R, Chao M, Takimoto C, et al. Population pharmacokinetics of magrolimab (5F9, Hu5F9-G4) in patients with solid tumors and lymphomas [Abstract]. Eleventh American Conference on Pharmacometrics (ACoP11) Virtual; 2020 09-13 November.

  BACKGROUND

• Maakaron JE, Asch A, Popplewell L, Collins GP, Flinn IW, Ghosh N, Keane C, Ku M, Mehta A, Roschewski M, Hacohen-Kleiman G, Huo Y, Zhang Y, Renard C, Smith SM, Advani R. Magrolimab plus rituximab with or without chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2024 Nov 26;8(22):5864-5874. doi: 10.1182/bloodadvances.2024013338.

  PMID: 39293083 DERIVED

• Mehta A, Popplewell L, Collins GP, Smith SM, Flinn IW, Bartlett NL, Ghosh N, Hacohen-Kleiman G, Huo Y, Su-Feher L, Renard C, Advani R, Roschewski M. Magrolimab plus rituximab in relapsed/refractory indolent non-Hodgkin lymphoma: 3-year follow-up of a phase 1/2 trial. Blood Adv. 2024 Nov 26;8(22):5855-5863. doi: 10.1182/bloodadvances.2024013277.

  PMID: 39213421 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

magrolimab; Rituximab; Gemcitabine; Oxaliplatin; Allopurinol

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 2, 2016
• Study Start: November 21, 2016
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (16); AU (3)