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    Summary
    EudraCT Number:2016-003408-29
    Sponsor's Protocol Code Number:5F9003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-01-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-003408-29
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of a new anti-CD47 antibody therapy with an approved therapy rituximab or Rituximab + Chemotherapy in patients with a cancer of B-cells, a type of white blood cell responsible for producing antibodies, which has returned after a period of improvement or that has proved resistant, or does not respond to, treatment
    A.4.1Sponsor's protocol code number5F9003
    A.5.4Other Identifiers
    Name:US IND NumberNumber:118300
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHu5F9-G4 (magrolimab)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmagrolimab
    D.3.9.3Other descriptive nameHu5F9-G4
    D.3.9.4EV Substance CodeSUB187222
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma.
    E.1.1.1Medical condition in easily understood language
    A cancer of B-cells, a type of white blood cell responsible for producing antibodies, which has returned after a period of improvement or that has proved resistant, or does not respond to, treatment.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012821
    E.1.2Term Diffuse large B-cell lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10029624
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10029601
    E.1.2Term Non-Hodgkin's lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10029600
    E.1.2Term Non-Hodgkin's lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10029623
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10029622
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10065856
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability, and to define the recommended Phase 2 doses (RP2D) 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 patients 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 as measured by the objective response rate (ORR) according to Lugano Classification for lymphomas (Cheson 2014; Table 10-1)
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetic (PK) profiles of magrolimab in combination with rituximab and magrolimab in combination with R-GemOx

    To evaluate the immunogenicity of magrolimab in combination with rituximab and magrolimab in combination with R-GemOx

    To evaluate the efficacy of magrolimab in combination with rituximab in indolent lymphoma and DLBCL and magrolimab in combination with R-GemOx in ASCT ineligible DLBCL as measured by the duration of response (DOR), progression free survival (PFS), overall survival (OS), and time to progression (TTP)

    To evaluate the efficacy of magrolimab in combination with rituximab in patients with indolent lymphoma and DLBCL and magrolimab in combination with R-GemOx in ASCT ineligible DLBCL as measured by ORR according to LYmphoma Response to Immunomodulatory therapy Criteria (LYRIC; Cheson 2016; Table 10-2)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults ≥ 18 years
    2. Antibody combination (magrolimab + rituximab) Phase 1b cohort only: B-cell NHL expressing CD20 by immunohistochemistry (IHC) or flow cytometry, relapsed or refractory to at least 2 prior lines of therapy
    3. DLBCL chemotherapy combination (magrolimab + R-GemOx) Phase 1b safety dose-escalation and expansion cohorts:
    a. Histologically confirmed de novo or transformed DLBCL relapsed or refractory to 1 to 3 prior lines of therapy who are not candidates for high dose chemotherapy and autologous stem cell transplantation (ASCT). Patients relapsed after ASCT are allowed.
    b. At least 1 prior therapy must have included a CD20-targeted therapy.
    c. Primary refractory patients are excluded as defined by failure to achieve a
    partial response (PR) or complete response (CR) to frontline therapy or progression within 3 months of completing treatment.
    d. The 1 to 3 prior lines of therapy requirement is only applicable for treatment regimens for DLBCL and not for prior lymphomas in the case of transformed DLBCL.
    4. For the DLBCL antibody combination (magrolimab + rituximab) Phase 2 cohort 4: De novo or transformed DLBCL, not otherwise specified according to the World Health Organization 2016 classification of lymphoid neoplasms (Swerdlow 2016) expressing CD20 by IHC or flow cytometry that is relapsed or refractory at least 2 prior lines of therapy containing and anti-CD20 therapy. Prior autologous hematopoietic cell transplantation is permitted.
    5. Indolent lymphoma Phase 2 Cohort: Histologically confirmed marginal zone
    or follicular lymphoma (Grade 1 to 3a) expressing CD20 by IHC or flow cytometry, relapsed or refractory to at least 2 prior lines of therapy
    6. Eastern Cooperative Oncology Group (ECOG) score 0 to 2
    7. Disease that is measurable or assessable for response per Lugano Classification for lymphomas (Cheson 2014; Table 10-1)
    8. Laboratory measurements, blood counts:
    • Hemoglobin ≥ 9.5 g/dL
    • Absolute neutrophil count (ANC) ≥ 1.0 × 109/mL
    • For the antibody combination (magrolimab + rituximab) Phase 1b and Phase 2 cohorts: Platelets ≥ 50 × 109/mL
    • For the Phase 1b chemotherapy combination (magrolimab + R-GemOx)
    safety dose-escalation and expansion cohorts only, platelets ≥ 100 × 109/mL
    9. Laboratory measurements, hepatic function:
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 5 × upper limit of normal (ULN)
    • Bilirubin ≤ 1.5 × or 3.0 × ULN and primarily unconjugated if patient has a documented history of Gilbert’s syndrome or a genetic equivalent
    10. Laboratory measurements, renal function:
    • Serum creatinine ≤ 1.5 × ULN or calculated glomerular filtration rate (GFR) > 40 mL/min/1.73 m2
    11. Women of childbearing potential (WOCBP) must not be nursing or planning to be pregnant and must have a negative urine or serum pregnancy test within 30 days before enrollment and within 72 hours before the first administration magrolimab.
    12. WOCBP must be willing to use at least 1 highly effective method of contraception during the study and continue for 4 months after the last dose of magrolimab and 12 months after the last dose of rituximab
    13. Male patients who are sexually active with a WOCBP and who have not had vasectomies must be willing to use a barrier method of contraception during and refrain from sperm donation during the study and for 4 months after the last dose of magrolimab and 12 months after the last dose of rituximab. If the partner is pregnant, male patients must use barrier method contraception (condom) during the study and for 4 months after the last dose of magrolimab and until there is a pregnancy outcome (whichever is applicable) to prevent fetal exposure to study drugs.
    14. Patient has provided informed consent
    15. Must be willing and able to comply with clinic visits and procedures outlined in the study protocol
    16. DLBCL chemotherapy combination (magrolimab + R-GemOx) Phase 1b safety dose-escalation and expansion cohorts and Phase 2 antibody combination (magrolimab + rituximab) indolent lymphoma and DLBCL cohorts: Willing to consent to 1 mandatory pretreatment and 1 on-treatment tumor biopsy, unless determined to not be feasible by the Investigator (Reasons include, but are not limited to, lack of accessible tumor tissue to biopsy and patient safety issues).
    17. CAR-T naïve or CAR-T ineligible patients and otherwise meet other inclusion/exclusion criteria may enroll. Patients who relapse following CAR-T therapy are not eligible.
    E.4Principal exclusion criteria
    1. Patients with active brain metastases. (Patients with stable treated central nervous system [CNS] lesions who are off corticosteroid therapy for at least 3 weeks are not considered active.)
    2. Prior allogeneic stem cell transplant
    3. Prior anti-cancer therapy including chemotherapy, hormonal therapy, and investigational agents within 3 weeks or within at least 4 half-lives prior to magrolimab dosing (up to a maximum of 4 weeks), whichever is longer. NOTE: Low dose steroids (oral prednisone or equivalent ≤ 20 mg per day), localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are not criteria for exclusion.
    4. Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV).
    5. Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of RBC transfusions during the 4-week period prior to screening. RBC transfusions are permitted during screening and prior to enrollment to meet the hemoglobin inclusion criteria.
    6. History of hemolytic anemia or Evans syndrome in the last 3 months.
    7. Positive IgG component of the direct antiglobulin test (DAT).
    8. Prior treatment with CD47 or signal regulatory protein alpha (SIRPĪ±)-targeting agents.
    9. Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancy for which patients are not on active anti-cancer therapy as defined in Exclusion Criterion 2.
    10. Hypersensitivity to the active substance, to murine proteins, or to any of the other excipients of rituximab listed in Appendix A.
    11. Significant medical diseases or conditions, as assessed by the Investigator and Sponsor that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, severely immunocompromised state, and congestive heart failure New York Heart Association (NYHA) Class II-IV.
    12. History of psychiatric illness or substance abuse likely to interfere with ability to comply with protocol requirements or give informed consent.
    13. Pregnancy or active breastfeeding.
    14. Additional exclusion criteria for DLBCL chemotherapy combination (magrolimab + R-GemOx) Phase 1b safety dose-escalation and expansion cohorts only:
    a. Undergone ASCT within a period of ≤ 3 months before signing informed consent.
    b. Prior treatment with gemcitabine and oxaliplatin. However, patients who relapse ≥ 12 months after treatment with a gemcitabine andoxaliplatin containing regimen are allowed.
    c. Known hypersensitivity to gemcitabine, oxaliplatin, or other platinum compounds.
    d. Intolerance of gemcitabine, oxaliplatin, and/or rituximab as monotherapy or in combination due to unacceptable toxicities as determined by the treating Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Dose-limiting toxicities (DLTs) (Phase 1b only) in the antibody combination (magrolimab + rituximab) and the chemotherapy combination (magrolimab + R-GemOx) cohorts]) and adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Dose limiting toxicities (Phase 1b only) in the antibody combination (magrolimab + rituximab) and the chemotherapy combination magrolimab + R-GemOx) cohorts]) and adverse events will be evaluated throughout the subject participation in the study.
    E.5.2Secondary end point(s)
    Concentration versus time measurements for magrolimab in combination with rituximab and for magrolimab in combination with R-GemOx and their PK parameters including maximum serum concentration (Cmax), and area under the concentration time curve (AUC).
    Anti-drug antibodies (ADA) to magrolimab in combination with rituximab and magrolimab in combination with R-GemOx
    • DOR, PFS, OS, and TTP
    • ORR as defined by the Investigator according to the LYRIC Criteria for lymphomas (Table 10-2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1b and 2: Concentration versus time measurements for magrolimab in combination with rituximab and PK parameters, including maximum plasma concentration (Cmax), time to maximum concentration (Tmax), terminal half-life (t1/2), area under the curve (AUC), clearance (CL), and volume of distribution during the terminal phase (Vz).
    • Phase 1b and 2: Anti-drug antibodies to magrolimab and rituximab.
    • Phase 2: Duration of response (DOR), best overall response (BOR), progression-free survival (PFS), and overall survival (OS).
    • Objective response as defined by the Investigator according to the LYRIC criteria for lymphomas.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, biomarkers
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Immunogenicity, biomarkers
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The date on which the last patient completes follow up for safety, disease progression or survival.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 72
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-04
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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