Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT04634435
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicities following Combination Product administration', 'timeFrame': '90-100 days post Combination Product administration'}, {'measure': 'Incidence and severity of side effects related to the Combination Product', 'timeFrame': '90-100 days post Combination Product administration'}], 'secondaryOutcomes': [{'measure': 'Rate of MRD (by ClonoSEQ®) conversion from positive to negative at 90-100 days after transplantation', 'timeFrame': '90-100 days post-ASCT'}, {'measure': 'Rate of MRD conversion from positive to negative', 'timeFrame': '1 year post-ASCT'}, {'measure': 'Rate of MRD conversion from positive to negative at any time during the maintenance phase', 'timeFrame': 'Start of maintenance therapy 90-100 days post ASCT until disease progression (approximately 2-3 years)'}, {'measure': 'Rate of PFS', 'timeFrame': '1 year post Combination Product administration'}, {'measure': 'Rate of OS', 'timeFrame': '1 year post Combination Product administration'}, {'measure': 'Best overall response rate per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma', 'timeFrame': '90-100 days post-ASCT, 1 year post-ASCT, and overall during maintenance phase (approximately 3 years)'}, {'measure': 'Incidence and severity of cytokine release syndrome per ASBMT consensus grading', 'timeFrame': '100 days post Combination Product administration'}, {'measure': 'Incidence and severity of other Immune-related toxicities by CTCAE version 5.0', 'timeFrame': '100 days post Combination Product administration'}, {'measure': 'PK of BHV-1100 by determining plasma Tmax', 'timeFrame': '4 days post Combination Product administration'}, {'measure': 'PK of BHV-1100 by determining plasma Cmax', 'timeFrame': '4 days post Combination Product administration'}, {'measure': 'PK of BHV-1100 by determining plasma Cmin', 'timeFrame': '4 days post Combination Product administration'}, {'measure': 'PK of BHV-1100 by determining plasma AUC', 'timeFrame': '4 days post Combination Product administration'}, {'measure': 'PK of BHV-1100 by determining plasma t1/2', 'timeFrame': '4 days post Combination Product administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cell Therapy', 'CIML NK cell therapy', 'cytokine induced memory-like natural killer cell therapy', 'immunotherapy', 'antibody-dependent cell-mediated cytotoxicity', 'ADCC', 'CD38 positive', 'CD38+', 'plasma cells', 'multiple myeloma', 'hematological malignancies'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is an open-label single center Phase 1a/1b study with the primary objective of establishing the safety and exploring the efficacy of infusing the ex vivo combination product of BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 in the peri-transplant setting in MM patients with minimal residual disease (MRD+) in first or second remission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had measurable disease according to Standard Diagnostic Criteria at the time of initial Multiple Myeloma diagnosis\n* Meets criteria for symptomatic multiple myeloma at the time of induction chemotherapy\n* Is transplant eligible based on clinician judgement\n* Willing to undergo ASCT in first or second remission\n* Achieve partial response or better with induction chemotherapy prior to ASCT according to the IMWG Uniform Response Criteria for Multiple Myeloma\n* Be MRD+ upon restaging prior to stem cell collection and ASCT\n* Eastern Cooperative Oncology Group (EGOG) performance status score of less than 2\n* Life expectancy greater than six months\n* Have a creatinine clearance \\> 45 mL/min/m2 at the time of transplant evaluation\n* If frozen stem cells from earlier mobilized leukapheresis are unavailable at the time of mobilized leukapheresis, patients must meet parameters/criteria according to institutional SOP for autologous stem cell apheresis\n* Be willing and clinically stable to undergo stem-cell mobilized and collect enough CD34+ cells sufficient for 2 ASCT per institutional guidelines or investigator discretion or have sufficient frozen cells from a SoC collection prior to signing study consent\n* Be willing and clinically stable to undergo a non-mobilized MNC-Apheresis while admitted to the hospital to generate CIML NK cells\n* Be willing to undergo maintenance after ASCT per NCCN guidelines based on disease risk\n* If a woman of child-bearing potential, be willing to follow birth control and pregnancy testing practice as recommended\n* Be willing to undergo bone marrow aspirate and biopsy as per treatment plan\n* Patients must meet adequate organ function/reserve based on institutional SOP for autologous stem cell transplant eligibility\n* Non-secretory MM can participate if they have measurable disease in the bone marrow and are amenable to be followed by MRD testing\n\nExclusion Criteria:\n\n* Prior autologous or allogeneic hematopoietic stem cell transplant\n* Prior cellular therapies, including NK cell therapy\n* Prior treatment with monoclonal antibodies, within 28 days of MCN apheresis\n* Prior treatment with high dose melphalan\n* Prior treatment with immunosuppressive or immunomodulatory agents with exception of 5 mg or less of prednisone daily, within 14 days of MCN-Apheresis\n* Disease progression at the time of study treatment\n* History of Plasma Cell Leukemia at any time prior to enrollment\n* Patients seropositive for the human immunodeficiency virus (HIV)\n* Uncontrolled, Hepatitis C Virus or Hepatitis B Virus infection\n* Patient receiving other investigational therapy\n* Patients with active, clinically significant autoimmune diseases\n* Patients with active, clinically significant cancer other than multiple myeloma\n* Patients with severe, uncontrolled psychiatric or neurological conditions that make difficult the assessment of neurologic toxicity of the study treatment\n* Patients who have received anti-MM therapy (with the exclusion of monoclonal antibodies) within 14 days of study treatment\n* More than two prior lines of anti-myeloma therapy, with induction therapy followed by maintenance being considered as one line and CyBorD to RVD transition in the absence of progressive disease being considered as one line'}, 'identificationModule': {'nctId': 'NCT04634435', 'briefTitle': 'Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biohaven Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1 Study of Autologous Memory-like Natural Killer (NK) Cell Immunotherapy With BHV-1100 and IVIG Followed by Low Dose IL-2 as Early Post-Autologous Transplant Consolidation in Minimal Residual Disease Positive, Multiple Myeloma (MM) Patients in First or Second Remission', 'orgStudyIdInfo': {'id': 'BHV1100-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BHV-1100 Combination Treatment', 'interventionNames': ['Combination Product: BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2']}], 'interventions': [{'name': 'BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2', 'type': 'COMBINATION_PRODUCT', 'description': 'Single dose infusion of BHV-1100 plus CIML NK Cells plus IVIG, followed by low dose IL-2', 'armGroupLabels': ['BHV-1100 Combination Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biohaven Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}