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    Summary
    EudraCT Number:2021-002339-44
    Sponsor's Protocol Code Number:IGM-2323-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-002339-44
    A.3Full title of the trial
    A Phase 1/2 Open-Label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects with Relapsed/Refractory Non-Hodgkin Lymphomas
    Estudio de fase I/II abierto y multicéntrico para evaluar la seguridad y la farmacocinética del aumento escalonado de dosis de IGM-2323 en sujetos con linfomas no Hodgkin recidivantes/resistentes al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Pharmacokinetic Study of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
    Estudio de seguridad y farmacocinética de IGM-2323 en sujetos con linfoma no Hodgkin recidivante/resistente
    A.4.1Sponsor's protocol code numberIGM-2323-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04082936
    A.5.4Other Identifiers
    Name:US IND NumberNumber:140504
    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 SponsorIGM Biosciences, 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 supportIGM Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIGM Biosciences, Inc.
    B.5.2Functional name of contact pointIGM Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address325 E. Middlefield Road
    B.5.3.2Town/ cityMountain View, CA
    B.5.3.3Post code94043
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@IGMbio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 nameIGM-2323
    D.3.2Product code IGM-2323
    D.3.4Pharmaceutical form 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 INNIGM-2323
    D.3.9.1CAS number 2573121-53-4
    D.3.9.2Current sponsor codeIGM-2323
    D.3.9.3Other descriptive nameIGM-2323
    D.3.9.4EV Substance CodeSUB235343
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    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 No
    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 (R/R) Non-Hodgkin lymphomas (NHL)
    Linfomas no Hodgkin (LNH) recidivantes/resistentes (R/R)
    E.1.1.1Medical condition in easily understood language
    Adult subjects with relapsed or refractory Non-Hodgkin Lymphoma
    Sujetos adultos con linfoma no Hodgkin recidivante o resistente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10025311
    E.1.2Term Lymphoma (non-Hodgkin's)
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1
    • To evaluate the safety and tolerability of IGM-2323 in subjects with R/R NHL
    • To determine a maximum tolerated dose (MTD) and/or a recommended Phase 2 dose (RP2D) and schedule of IGM-2323 as a single agent in subjects with R/R NHL

    Phase 2 Expansion
    • To select the optimally efficacious dose of IGM-2323 in subjects with R/R diffuse large B-cell lymphoma
    (DLBCL) and R/R follicular lymphoma (FL)
    Fase I
    • Evaluar la seguridad y la tolerabilidad de IGM-2323 en sujetos con LNH R/R
    • Determinar una dosis máxima tolerada (DMT) o una dosis recomendada para la fase II (DRF2) y una pauta de IGM-2323 en monoterapia en sujetos con LNH R/R

    Ampliación de fase II
    • Seleccionar la dosis eficaz de manera óptima de IGM-2323 en sujetos con linfoma difuso de células B grandes (LDCBG) R/R y linfoma folicular (LF) R/R
    E.2.2Secondary objectives of the trial
    • To evaluate the pharmacokinetic (PK) profile of IGM-2323
    • To evaluate the immunogenicity of IGM-2323
    • To assess preliminary efficacy of IGM-2323 in subjects with R/R NHL
    • To assess preliminary efficacy of IGM-2323 in subjects who have received prior bispecific T-cell engager treatment
    • Evaluar el perfil farmacocinético (FC) de IGM-2323
    • Evaluar la inmunogenia de IGM-2323
    • Evaluar la eficacia preliminar de IGM-2323 en sujetos con LNH R/R
    • Evaluar la eficacia preliminar de IGM-2323 en sujetos que han recibido un tratamiento previo con un activador biespecífico de linfocitos T
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Below is a summary of the principal inclusion criteria. Please refer to protocol for all inclusion criteria.
    • >/= 18 years of age: ECOG PS 0 or 1
    • Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL)
    • Also Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation
    • Relapsed or refractory to at least 2 prior systemic treatment regimens (must include anti-CD20 based chemoimmunotherapy regimen)
    • FL and MZL may be enrolled with at least 2 prior systemic regimens which must have included an anti-CD20 therapy (and without need for a prior chemotherapy regimen)
    • For subjects in Cohort G3, prior CD20 x CD3 bispecific T-cell engagers may be enrolled, provided that they did not have Grade 2 or higher CRS on their previous treatment and completed at least 2 cycles of their prior treatment
    • At least one bi-dimensionally measurable lesion (≥1.5cm in it’s longest dimension by computerized tomography (CT scan)
    • Good organ and bone marrow function, evidenced by laboratory assessments
    • Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemo resistant disease, medically unfit (organ function), or unwilling
    • All patients must have at least 1 tumor site that can be biopsied and be willing to have pre-treatment and on-treatment biopsies
    - Subjects for whom biopsies are medically contraindicated or for whom the treating physician does not feel that it is in the best interest of the subject may still enter the study after a discussion with the study Sponsor.
    - Site of biopsy should be distinct from target lesions used for efficacy assessment
    A continuación se muestra un resumen de los principales criterios de inclusión. Consulte el protocolo para conocer todos los criterios de inclusión.
    • Edad ≥18 años: estado funcional de 0 o 1 según el ECOG
    • Linfoma folicular (LF) recidivante o resistente y linfoma difuso de linfocitos B grandes (LDLBG)
    • También linfoma de células del manto (LCM), linfoma de la zona marginal (LZM) durante el periodo de escalada de dosis
    • Recidivante o resistente como mínimo a 2 pautas terapéuticas sistémicas anteriores (debe incluir una pauta de inmunoquimioterapia anti-CD20)
    • Los casos de LF y el LZM pueden inscribirse como mínimo con 2 pautas sistémicas anteriores que deben haber incluido un tratamiento anti-CD20 (y sin necesidad de una pauta de quimioterapia anterior)
    • En el caso de los pacientes de la cohorte G3, se puede incluir a aquellos que hayan recibido anteriormente ligadores biespecíficos del linfocito T CD20 × CD3, siempre que no tuvieran un SLC de grado 2 o superior en su tratamiento anterior y completaran al menos 2 ciclos de su tratamiento anterior
    • Al menos una lesión medible bidimensionalmente (≥1,5 cm) en la dimensión más larga mediante tomografía axial computarizada (TAC)
    • Función de médula ósea y de órganos adecuada, demostrado mediante evaluaciones analíticas
    • No apto para trasplante autólogo de células madre (sujetos con LDCBG), debido a enfermedad quimiorresistente, falta de aptitud médica (función orgánica) o falta de voluntad
    • Todos los pacientes deben tener al menos 1 sitio del tumor en el que se pueda realizar una biopsia y estar dispuestos a someterse a biopsias anteriores al tratamiento y durante este
    - Los pacientes podrán seguir ingresando al estudio tras discutirlo con el promotor del estudio en caso de contraindicación médica para someterse a biopsias, o si el médico responsable del tratamiento opina que no es lo mejor para el paciente
    - El lugar de la biopsia debe ser distinto de las lesiones diana utilizadas para la evaluación de la eficacia
    E.4Principal exclusion criteria
    Below is a summary of the principal exclusion criteria. Please refer to protocol for all exclusion criteria.
    • Known Double/Triple Hit Lymphoma, CLL, or Richters transformation
    • Known lack of cancer cell CD20 expression by IHC, flow cytometry, gene expression or another assay
    • Prior allogeneic transplant or organ transplant
    • ASCT within 100 days prior to the first IGM-2323 administration
    • Prior treatment with CD3 engaging bispecific antibodies (except for Phase I/Stage IV Group 3)
    • Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval
    • Concurrent serious co-morbidities that could limit patients’ full participation and compliance
    • Prior use of any mAB, systemic immunotherapeutic agent or small molecule target therapy within 3 weeks of first dose of IGM-2323
    • Treatment with radiotherapy within 1 week prior to the first IGM-2323 administration
    - If subjects have received radiotherapy within 4 weeks prior to the first IGM-2323 administration, subjects must have at least 1 measurable lesion outside of the radiation field
    - Subjects who have only 1 measurable lesion that was previously irradiated but subsequently progressed are eligible
    • Current central nervous system (CNS) lymphoma (history of CNS lymphoma allowed if in remission, no evidence of disease by head magnetic resonance imaging [MRI], and not requiring steroid therapy)
    • Known active and clinically significant infection requiring treatment with IV antibiotics or hospitalization within 4 weeks of first IGM-2323 dose
    • Acute or chronic HCV infection, known history of HIV seropositivity
    • Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide and the anti-tumor necrosis factor agents) with the exception of corticosteroid treatment ≤ 10 mg/day prednisone or equivalent within 2 weeks prior to first dose of IGM-2323
    • History of unstable angina, MI, cardiac angioplasty or stenting, or pulmonary embolism within 6 months of enrollment
    • Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment, or indicating subject would unlikely have potential benefit
    A continuación se muestra un resumen de los principales criterios de exclusión. Consulte el protocolo para conocer todos los criterios de exclusión.
    • Linfomas con mutación doble y triple, LLC o transformación de Richter
    • Ausencia conocida de expresión de CD20 en células cancerosas medida mediante inmunohistoquímica (IHQ), citometría de flujo, expresión génica u otro análisis
    • Alotrasplante o transplante de órganos anterior
    • ATHB en los 100 días anteriores a la primera administración de IGM-2323
    • Tratamiento previo con anticuerpos biespecíficos que actúan sobre CD3 (excepto en el grupo 3 de fase I/estadio IV)
    • Ausencia de respuesta al tratamiento anterior con CAR-T, pacientes en los que han transcurrido menos de 3 meses desde el tratamiento anterior con CAR-T hasta la primera dosis de IGM-2323 y tratamiento anterior con CAR-T. Estos pacientes solo están permitidos con la aprobación del supervisor médico
    • Comorbilidades graves simultáneas que podrían limitar la participación total y el cumplimiento de los pacientes
    • Uso anterior de cualquier Acm, agente inmunoterapéutico sistémico o proteína terapéutica, en las 3 semanas anteriores a la primera dosis de IGM-2323
    - Si los pacientes han recibido radioterapia en las 4 semanas anteriores a la primera administración de IGM-2323, deben presentar al menos 1 lesión medible fuera del campo de irradiación
    - Son aptos los pacientes que tengan solo 1 lesión medible que haya sido irradiada anteriormente pero que haya progresado posteriormente
    • Linfoma actual del sistema nervioso central (SNC) (se permiten antecedentes de linfoma del SNC si está en remisión, no hay signos de enfermedad mediante resonancia magnética [RM] de la cabeza y no requiere tratamiento con corticosteroides)
    • Infección activa conocida clínicamente significativa que precise tratamiento con antibióticos i.v. u hospitalización en las 4 semanas anteriores a la primera administración de IGM-2323
    • Infección por el VHC aguda o crónica, antecedentes conocidos de seropositividad para el VIH
    • Administración de inmunosupresores sistémicos (entre otros, ciclofosfamida, azatioprina, metotrexato, talidomida, y fármacos contra el factor de necrosis tumoral) a excepción del tratamiento de corticosteroides con ≤10 mg/día de prednisona o equivalente en las 2 semanas anteriores a la primera dosis de IGM-2323
    • Angina inestable, infarto de miocardio, angioplastia cardíaca o colocación de endoprótesis vascular en los últimos 6 meses
    • Cualquier enfermedad o anomalía en el análisis que pueda interferir en la evaluación de la seguridad o la eficacia del tratamiento del estudio, o que indique que el paciente probablemente no reciba un posible beneficio o termine el estudio
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of adverse events (AEs), serious adverse events (SAEs) and DLT according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5)

    Phase 2 Expansion:
    • Overall response rate (ORR) as determined by study Investigators according to the Lugano Classification in Lymphoma
    • Incidencia de acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y TLD de acuerdo con la versión 5.0 (v5) de los Criterios Terminológicos Comunes para Acontecimientos Adversos del Instituto Nacional del Cáncer (CTCAE del NCI).

    Ampliación de fase II:
    • Tasa de respuesta global (TRG) según lo determinado por los investigadores del estudio de acuerdo con la clasificación de Lugano para el linfoma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: first dose up to 30 days after last dose

    ORR: Week 6, 12, 24, then every 3 months
    Seguridad: Primera dosis hasta 30 días después de la última dosis

    TRG: Semanas 6, 12, 24 y, a continuación, cada 3 meses
    E.5.2Secondary end point(s)
    • PK: area under the curve, clearance (CL), maximum concentration (Cmax), terminal half-life (t1/2), and volume of distribution (Vd) of IGM-2323
    • Incidence of anti-drug antibodies (ADAs)
    • ORR in Phase 1, duration of response (DOR), and progression free survival (PFS), as determined by study Investigators according to the Lugano Classification in Lymphoma
    • ORR, DOR, and PFS as determined by study Investigators in subjects with prior bispecific T-cell engager treatment
    • Complete response rate (CRR) and duration of CR in all tumor types
    • Overall survival (OS)
    • FC: área bajo la curva (ABC0-t), aclaramiento (Cl), concentración máxima (Cmáx), semivida terminal (t1/2) y volumen de distribución (Vd) de IGM-2323
    • Incidencia de anticuerpos antifármaco (AAF)
    • TRG en la fase I, duración de la respuesta (DR) y supervivencia sin progresión (SSP), según lo determinado por los investigadores del estudio de acuerdo con la clasificación de Lugano para el linfoma
    • TRG, DR y supervivencia sin progresión (SSP) según lo determinado por los investigadores del estudio en sujetos con un tratamiento previo con un activador biespecífico de linfocitos T
    • Tasa de respuesta completa (TRC) y duración de la RC en todos los tipos de tumores
    • Supervivencia general (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: Refer to PK timepoints in attached Protocol IGM-2323-001, Section 8.8.2

    ADA: Refer to ADA Assessment timepoints in Protocol IGM-2323-001, Section 8.8.6

    Survival: First dose until time of death or loss to follow up
    FC: Consulte los puntos temporales de FC en el protocolo IGM-2323-001 adjunto, sección 8.8.2

    AAF: Consulte los puntos temporales de evaluación de AAF en el protocolo IGM-2323-001, sección 8.8.6

    Supervivencia: Primera dosis hasta el momento de la muerte o la pérdida para el seguimiento
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    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.8.2.4Number of treatment arms in the trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Canada
    Korea, Republic of
    United States
    France
    Spain
    Czechia
    Italy
    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 end of study is defined as the timepoint when the final data for a clinical study have been collected, which is after the last patient has made the final visit to the study location.
    El final del estudio se define como el momento en el que se han recogido los datos finales de un estudio clínico, que es después de que el último paciente haya realizado la visita final a la ubicación del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years5
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 260
    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)
    Post-treatment, subjects will be observed for disease progression until next therapy, for drug related SAEs, and survival until death or until withdrawal of consent, or the end of the study, whichever occurs first. Based upon further review of available safety, PK, PD, and efficacy, length of IGM-2323 treatment may be extended.
    Después del tratamiento, se observará a los sujetos para detectar progresión de la enfermedad hasta el siguiente tratamiento, para AAG relacionados con el fármaco y supervivencia hasta la muerte o hasta la retirada del consentimiento o el final del estudio, lo que ocurra primero. Basándose en una revisión adicional de la seguridad, FC, FD y eficacia disponibles, la duración del tratamiento con IGM-2323 puede ampliarse.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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